This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant (NCT05959447), a non-randomized phase 1 study. The primary outcome is Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05959447 |
| Phase | Phase 1 |
| Condition | Cough, Healthy |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bellus Health Inc. - a GSK company |
| Results posted | Yes |
2. Clinical Question
Population
Healthy participants studied under fasting conditions. The registry record reports an enrollment of 45. It does not describe a patient population with cough as the participants in the pharmacokinetic analysis.
Intervention
Part 1 examined camlipixant 50 mg alone and with gemfibrozil 600 mg. The record describes camlipixant as a single oral dose and gemfibrozil as repeated oral doses. Part 2 examined dabigatran etexilate 150 mg and camlipixant 50 mg in a fixed sequence, including co-administration.
Comparator
The comparisons are within the study’s fixed-sequence treatment periods, rather than randomized parallel treatment groups. In Part 1, camlipixant exposure when given alone is relevant to its exposure when given with gemfibrozil. Part 2 includes pharmacokinetic outcomes for free dabigatran. The registry record does not report a randomized control comparison.
Primary question
In Part 1, the primary outcome is camlipixant area under the concentration-time curve from time zero to infinity (AUC-inf), measured when camlipixant is given alone and in combination with gemfibrozil. The record does not report the estimated exposure under either condition or an interaction estimate. It therefore does not establish the magnitude or precision of any change in camlipixant exposure.
3. Trial Design
This is a Phase 1, two-part, open-label, fixed-sequence study, listed as completed. It was nonrandomized and had no masking. The study record gives an enrollment of 45 and describes the participants as healthy and studied under fasting conditions. Its focus is pharmacokinetic interaction assessment, not a treatment comparison for cough.
Part 1 concerns camlipixant and gemfibrozil. The listed regimen begins with a single oral dose of camlipixant 50 mg on Day 1, followed by repeated oral doses of gemfibrozil 600 mg twice daily on Days 5 to 11. The arm description also specifies co-administration of a single dose of camlipixant with gemfibrozil. The primary outcome description identifies camlipixant profiles on Day 1 and Day 9, when administered alone and in combination.
Part 2 concerns dabigatran etexilate and camlipixant. The record describes a single oral dose of dabigatran etexilate 150 mg on Day 1, followed by repeated oral doses of camlipixant 50 mg twice daily from Days 5 to 9, with co-administration of a single dose of dabigatran etexilate. Listed secondary outcomes in this part include time to maximum observed concentration and terminal elimination half-life for free dabigatran.
In general, a fixed-sequence design assesses treatments in an assigned order rather than assigning participants randomly to concurrent treatment groups. Open-label means masking was not used. These features matter when interpreting comparisons: treatment period and sequence are part of the context, and this design does not offer the same randomized, masked comparison as a conventional parallel-group trial. The registry record does not report a randomized allocation or a masked assessment.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 45 participants were enrolled in the study (25 participants in Part 1 and 20 participants in Part 2). Only 32 participants (13 participants were never dosed) were dosed into the study to receive either camlipixant + gemfibrozil or dabigatran etexilate+ camlipixant creating the Safety Population. (The safety population included all participants who received at least one dose of any study drug).
Part 1 (Up to Day 21)
| Stage | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg |
|---|---|---|
| STARTED | 25 | 0 |
| Safety Population | 16 | 0 |
| COMPLETED | 15 | 0 |
| NOT COMPLETED | 10 | 0 |
Reasons for not completing this period:
| Reason | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg |
|---|---|---|
| Adverse Event | 1 | 0 |
| Enrolled but did not receive study treatment | 9 | 0 |
Part 2 (Up to Day 22)
| Stage | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg |
|---|---|---|
| STARTED | 0 | 20 |
| Safety Population | 0 | 16 |
| COMPLETED | 0 | 14 |
| NOT COMPLETED | 0 | 6 |
Reasons for not completing this period:
| Reason | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg |
|---|---|---|
| Adverse Event | 0 | 2 |
| Enrolled but did not receive study treatment | 0 | 4 |
Analysis population for the primary outcome, as defined in the registry: The PK parameter Population included all participants for whom the Day 1 and Day 9 PK profiles of the camlipixant could be adequately characterized, specifically, when administered alone and in combination with gemfibrozil (Part 1)
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Baseline characteristics are reported for the Safety Population which consisted of all participants who received at least one dose of any study drug.
| Characteristic | Unit | Part 1: Camlipixant 50 mg + Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg + Camlipixant 50 mg | Total |
|---|---|---|---|---|
| Participants analysed | 16 | 16 | 32 | |
| Age, Customized: 23 to 54 years | Participants | 16 | 16 | 32 |
| Sex: Female, Male: Female | Participants | 7 | 7 | 14 |
| Sex: Female, Male: Male | Participants | 9 | 9 | 18 |
| Race/Ethnicity, Customized: All Other Races | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: White | Participants | 14 | 14 | 28 |
6. Primary Endpoint
The registry lists the primary outcome as Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC-inf) of Camlipixant, measured over Pre-dose, 0.25 , 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48, 72 hours post-dose on Day 1 and Day 9.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | Hours*nanograms per milliliter |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is Part 1 camlipixant AUC-inf: the area under the concentration-time curve from time zero to infinity. AUC is a pharmacokinetic measure of drug exposure over time. Extending the curve to infinity includes an estimated terminal portion beyond the last observed concentration, so the value represents total exposure rather than concentration at a single sampling time.
Blood samples for pharmacokinetic analysis were collected before dosing and at the listed post-dose times: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18, 24, 48 and 72 hours on Day 1 and Day 9. The registry record says that standard non-compartmental methods were used. The outcome is expressed in hours*nanograms per milliliter, with a geometric mean and geometric coefficient of variation specified.
In general, AUC is useful in interaction studies because it captures exposure across a dosing interval or profile, whereas a single concentration reflects only one sampling time. Comparing AUC under the study’s alone and combination conditions can characterize whether exposure differs in the presence of gemfibrozil. The registry record does not report the AUC values, an estimated contrast, or uncertainty around that contrast. The endpoint definition alone therefore does not quantify an interaction.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a pharmacokinetic question, but does not report the primary outcome result. It names Part 1 camlipixant AUC-inf as the primary outcome and describes the concentration sampling and analysis approach. It does not give the geometric means, geometric coefficients of variation, a comparison between camlipixant alone and with gemfibrozil, or a confidence interval. Without those results, the size and precision of any exposure difference cannot be assessed from the registry record.
That distinction is important. Naming an endpoint and describing its measurement does not establish what was observed. The design is intended to examine drug-drug interactions, but the study title or stated purpose is not itself evidence of the direction or magnitude of an interaction. The record does not report whether camlipixant exposure was higher, lower, or similar under combination conditions. No conclusion about the observed pharmacokinetic effect can be drawn from the outcome description alone.
The two parts address different drug pairs and different outcomes. Part 1’s primary outcome concerns camlipixant exposure in relation to gemfibrozil. Part 2 lists outcomes concerning free dabigatran, including its maximum observed concentration timing and terminal elimination half-life. These are not interchangeable endpoints: they measure different aspects of concentration profiles and involve different drugs. Part 2 results are not reported in the registry record, and the registry record does not identify a Part 2 primary outcome in the listed primary outcome information.
The design also limits the nature of the comparison. It is nonrandomized, open-label and fixed-sequence. As a general statistical point, the absence of randomization means treatment order is not randomized across groups, and an open-label design does not conceal treatment assignment. Those characteristics do not invalidate pharmacokinetic measurements, but they are relevant context when interpreting comparisons and assessing possible sources of bias. This is not a like-for-like randomized comparison.
The registry record reports that the study is completed, but completion does not substitute for results. It does not report the analysis estimates, confidence intervals, p-values, or outcome-specific analysis populations beyond the primary outcome population description. Consequently, statistical significance and precision cannot be assessed. The record also does not report whether any interaction met a prespecified threshold for clinical importance. No judgment about clinical consequences follows from the endpoint name or study design alone.
For safety, the record gives counts of participants with serious and other adverse events in listed treatment groups. These counts describe reported events in those groups; they do not supply a comparative statistical analysis. Because the design is not randomized and the record does not explain a formal safety comparison, differences in group counts should not be treated as estimates of a causal treatment effect.
9. Statistical Methods Explained
The primary outcome is a pharmacokinetic measure, not a clinical symptom or disease outcome. It summarizes concentration over time, with the study’s stated interest being camlipixant exposure when administered alone and in combination with gemfibrozil. The registry record says the analysis used standard non-compartmental methods. It does not report a detailed statistical analysis plan, model specification, or numerical outcome estimates.
What does AUC-inf represent?
As a general statistical and pharmacokinetic explanation, area under the concentration-time curve summarizes drug exposure across a measured concentration profile. The “inf” indicates that the curve is extended from the final observed concentration toward infinity using an estimate of the terminal part of the profile. This is why AUC-inf is not simply one of the measured blood concentrations. Its value depends on the observed profile and on estimation of the terminal portion. The registry record does not report the percentage of AUC attributed to extrapolation for the primary outcome.
The sampling schedule is intended to characterize concentrations over an extended period after dosing. The listed collection times run from pre-dose through 72 hours after dose on Day 1 and Day 9. In general, multiple time points help describe the rise and decline of concentration, while the extrapolated tail helps estimate total exposure beyond the last sample. The schedule itself does not show the observed concentrations or the quality of each participant’s profile.
Why report a geometric mean?
The primary outcome is specified as a geometric mean with a geometric coefficient of variation. As a general statistical explanation, a geometric mean is often used for positive pharmacokinetic measurements that are analyzed on a logarithmic scale or that vary multiplicatively. It describes a central value in the original scale after accounting for that log-scale analysis. A geometric coefficient of variation describes relative variability around geometric-scale measurements; it is not the same as a standard deviation in the original units.
These summaries would help readers understand both typical exposure and variability across the analyzed profiles. However, neither the geometric mean nor its variability is numerically reported for the primary outcome in the registry record. The method label alone does not indicate whether variability was small or large, nor does it quantify a difference between treatment conditions.
How should uncertainty be interpreted?
In general, a confidence interval describes a range of values compatible with the data and the analysis method, and indicates the precision of an estimated effect. A point estimate without an uncertainty interval can leave considerable ambiguity about the plausible size of an effect. For this study, the registry record does not report an interaction estimate or confidence interval for camlipixant AUC-inf. It also does not report a p-value for that outcome. Thus, the precision and statistical evidence for a contrast cannot be evaluated from the record.
A p-value, in general, concerns how compatible the observed data are with a specified null model under stated assumptions; it does not give the probability that a hypothesis is true or describe the clinical importance of an effect. No p-value for the primary outcome is reported. Even if a significance result were available, a separate assessment of the effect size and its clinical relevance would still be needed. The registry record does not report a threshold for interpreting an interaction as clinically important.
What does the design contribute?
The fixed-sequence design assesses treatment conditions in an ordered sequence, and the study is described as nonrandomized and open-label. In general, sequence-based pharmacokinetic studies can compare profiles under different conditions within the study’s planned order. Such a design should not be described as a randomized comparison, and it does not eliminate possible effects associated with time or sequence. The record does not report enough detail to characterize any washout rationale, period-effect analysis, or adjustment for sequence-related factors.
Part 1 and Part 2 have distinct drug combinations and outcome measures. Part 1’s primary measure is camlipixant AUC-inf. Part 2’s listed secondary measures include time to maximum observed concentration and terminal elimination half-life of free dabigatran. In general, time to maximum concentration describes when the peak is observed, while terminal half-life describes the decline in the terminal phase. Neither measure is a substitute for AUC. No Part 2 numerical estimates are reported in the registry record.
The registry record describes the primary pharmacokinetic population as participants whose Day 1 and Day 9 camlipixant profiles could be adequately characterized when administered alone and with gemfibrozil. This is an analysis-population definition based on profile evaluability. It does not state how many participants met that criterion or how profiles judged inadequate were handled in the analysis.
The record also gives assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. In general, such calculations are planning illustrations, not observed power and not evidence that a trial was designed with those assumptions. The registry record does not report the trial’s sample-size justification or the numerical outputs of any planning illustration.
10. Multiplicity, Missing Data and Analysis Populations
The study has two parts and lists multiple outcomes. Part 1 includes the primary outcome of camlipixant AUC-inf and secondary pharmacokinetic measures such as time to maximum observed concentration, terminal elimination half-life, percentage of AUC-inf due to extrapolation, terminal elimination rate constant, apparent clearance and apparent volume of distribution. Part 2 lists outcomes for free dabigatran. Testing or estimating multiple outcomes can raise questions about multiplicity: in general, the more inferential comparisons made, the more important it is to understand which were prespecified and how results were interpreted together.
The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a detailed statistical analysis plan. It also does not describe interim analyses. Those details are therefore not reported in the registry record; they should not be inferred from the outcome list or the study’s completion status.
The primary outcome population is defined as participants whose Day 1 and Day 9 camlipixant profiles could be adequately characterized under both conditions in Part 1. The record does not report the number included in that population, the amount or pattern of missing pharmacokinetic data, or the method used to handle incomplete or unevaluable profiles. It also does not report how missing data were treated for the secondary outcomes.
These omissions limit assessment of how the analysis population relates to enrollment and whether exclusions could have affected the estimates. In general, missingness can matter when the availability of measurements is related to participant characteristics or observed concentrations. The registry record does not provide information that would establish whether this occurred. The listed enrollment and outcome-population definition should therefore be kept distinct from the number of participants contributing to any particular analysis, which is not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Part 1: Camlipixant 50 mg | 0 | 16 | 0.0% |
| Part 1: Gemfibrozil 600 mg | 0 | 16 | 0.0% |
| Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 1 | 16 | 6.2% |
| Part 2: Dabigatran Etexilate 150 mg | 0 | 16 | 0.0% |
| Part 2: Camlipixant 50 mg | 0 | 15 | 0.0% |
| Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg | 0 | 14 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part 1: Camlipixant 50 mg | 0 of 16 |
| Part 1: Gemfibrozil 600 mg | 0 of 16 |
| Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 0 of 16 |
| Part 2: Dabigatran Etexilate 150 mg | 0 of 16 |
| Part 2: Camlipixant 50 mg | 0 of 15 |
| Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg | 0 of 14 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part 1: Camlipixant 50 mg | 1 of 16 |
| Part 1: Gemfibrozil 600 mg | 6 of 16 |
| Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | 5 of 16 |
| Part 2: Dabigatran Etexilate 150 mg | 4 of 16 |
| Part 2: Camlipixant 50 mg | 6 of 15 |
| Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg | 0 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Part 1: Camlipixant 50 mg | Part 1: Gemfibrozil 600 mg | Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg | Part 2: Camlipixant 50 mg | Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg |
|---|---|---|---|---|---|---|---|
| Hepatic enzyme increased | Investigations | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 15 | 0 of 14 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part 1: Camlipixant 50 mg | Part 1: Gemfibrozil 600 mg | Part 1: Camlipixant 50 mg+ Gemfibrozil 600 mg | Part 2: Dabigatran Etexilate 150 mg | Part 2: Camlipixant 50 mg | Part 2: Dabigatran Etexilate 150 mg+ Camlipixant 50 mg |
|---|---|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | 1 of 16 | 1 of 16 | 0 of 16 | 1 of 16 | 1 of 15 | 0 of 14 |
| Headache | Nervous system disorders | 0 of 16 | 0 of 16 | 1 of 16 | 1 of 16 | 1 of 15 | 0 of 14 |
| Abdominal pain | Gastrointestinal disorders | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 16 | 2 of 15 | 0 of 14 |
| Faeces soft | Gastrointestinal disorders | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 16 | 1 of 15 | 0 of 14 |
| Alanine aminotransferase increased | Investigations | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 16 | 1 of 15 | 0 of 14 |
| Aspartate aminotransferase increased | Investigations | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 16 | 1 of 15 | 0 of 14 |
| Palpitations | Cardiac disorders | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 15 | 0 of 14 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 15 | 0 of 14 |
| Thyroxine free decreased | Investigations | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 15 | 0 of 14 |
| Dysgeusia | Nervous system disorders | 0 of 16 | 0 of 16 | 1 of 16 | 0 of 16 | 0 of 15 | 0 of 14 |
Serious events with the highest arm-level rate: hepatic enzyme increased (6.2%).
The registry record reports serious adverse event counts by listed treatment group. In Part 1, the camlipixant 50 mg group had 0 serious adverse events among 16 at risk; the gemfibrozil 600 mg group had 0 among 16; and the camlipixant 50 mg plus gemfibrozil 600 mg group had 1 among 16. In Part 2, the dabigatran etexilate 150 mg group had 0 among 16, the camlipixant 50 mg group had 0 among 15, and the combination group had 0 among 14. The record reports 0 deaths in each listed group.
It also reports other adverse events affecting 1 participant in the Part 1 camlipixant group, 6 in the gemfibrozil group, 5 in the Part 1 combination group, 4 in the Part 2 dabigatran group, 6 in the Part 2 camlipixant group, and 0 in the Part 2 combination group. The registry record lists “Hepatic enzyme increased” among the top serious terms, with 6.2%. It does not identify that term’s treatment group in the information.
These are descriptive counts, not a randomized safety comparison. The nonrandomized, fixed-sequence design and the different group sizes mean the counts should not be read as causal treatment effects. Zero recorded events in a group does not establish that an event cannot occur.
12. What the Result Does, and Does Not, Mean
The registry record describes a Phase 1 pharmacokinetic interaction study in healthy participants under fasting conditions. Its primary outcome is camlipixant AUC-inf in Part 1, assessed when camlipixant is administered alone and in combination with gemfibrozil. The study also has a second part involving dabigatran etexilate and camlipixant, with listed outcomes for free dabigatran.
What the record does not report is just as important for interpretation. It contains no numerical result for the primary outcome, no estimated difference or ratio between conditions, and no confidence interval or p-value. It therefore cannot establish from the registered results the direction, size, or precision of a camlipixant exposure change. The Part 2 outcome estimates are also not reported in the registry record.
The study’s purpose is to assess potential drug-drug interactions, but a study question is not a finding. Nor does completion by itself tell readers what the concentration measurements showed. The available safety counts are descriptive and do not establish a comparative safety effect. No medical recommendation follows from these registry entries.
As a general statistical point, interpreting pharmacokinetic evidence requires the actual estimates, their uncertainty, and context about the analysis population and methods. Even a clearly estimated change in exposure would not, by itself, answer every question about clinical outcomes or effects in populations beyond the healthy participants studied. This record does not report such clinical outcome evidence, nor does it provide a clinical threshold for interpreting an interaction.
13. Why This Trial Matters Statistically
Drug-drug interaction studies address whether one medicine changes the concentration profile of another when used together. Pharmacokinetic outcomes such as AUC-inf, maximum observed concentration, and terminal half-life describe different features of that profile. The study is statistically relevant because it separates two drug-pair questions into distinct parts and names the corresponding outcome measures rather than treating all pharmacokinetic effects as one result.
Part 1 focuses on camlipixant exposure with and without gemfibrozil, using AUC-inf as its primary outcome. Part 2 focuses on dabigatran etexilate with camlipixant and lists outcomes for free dabigatran. The fixed-sequence, nonrandomized, open-label design is also relevant: readers should distinguish an ordered pharmacokinetic comparison from a randomized parallel-group trial. The design determines what kinds of comparisons can be made and what limitations need consideration.
The registry record is also a reminder that outcome definitions and results are separate pieces of evidence. Detailed concentration sampling and a named analysis method explain how an outcome was intended to be characterized, but they do not reveal the observed effect. Without estimates and measures of uncertainty, the magnitude and precision of the primary outcome cannot be evaluated.
Finally, the listed safety counts offer descriptive context, while not supplying a randomized comparative analysis. For statistical interpretation, the design, the population actually analyzed, the estimates, and their uncertainty all matter. Several of those results and analysis details are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting efficacy-related or pharmacokinetic findings is that numerical results for the primary outcome are not reported in the registry record. There is no reported AUC-inf estimate for either condition, no contrast, and no confidence interval or p-value. The registry record also does not report numerical results for the listed Part 2 outcomes. This prevents assessment of effect magnitude and precision.
The study is nonrandomized, open-label, and fixed-sequence. It is therefore not a randomized like-for-like comparison, and treatment sequence is part of the design context. The registry record does not describe any adjustment or analysis addressing possible period or sequence effects. It also does not report a washout rationale or the detailed statistical analysis plan.
The study population is described as healthy participants under fasting conditions. The record does not establish how pharmacokinetic findings would apply beyond that study context. The primary analysis population is defined by adequate characterization of Day 1 and Day 9 profiles, but the number meeting that definition and the handling of unevaluable profiles are not reported in the registry record.
Multiplicity procedures, interim analyses, and a sample-size justification are not reported in the registry record. Safety figures are presented as group counts without a randomized comparative analysis. These limitations do not establish that the study’s conduct was inadequate; they identify information absent from the registry record that would be needed for fuller statistical interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant — NCT05959447.
- Registry record last updated 2025-03-26; status last verified 2025-03.
- Results first posted 2025-03-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT05959447, a completed Phase 1, two-part, open-label, nonrandomized, fixed-sequence study of potential interactions involving camlipixant, gemfibrozil, and dabigatran etexilate. It enrolled 45 healthy participants under fasting conditions.
Part 1’s primary outcome is camlipixant AUC-inf, based on concentration profiles when administered alone and with gemfibrozil. Part 2 lists pharmacokinetic outcomes for free dabigatran. The record specifies a geometric mean and geometric coefficient of variation for the primary outcome, and describes standard non-compartmental pharmacokinetic analysis.
Numerical primary and Part 2 outcome results, uncertainty estimates, detailed analysis methods, and the sample-size justification are not reported in the registry record. Safety counts are reported by treatment group, but the design does not provide a randomized comparative safety assessment.