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 Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers (NCT06699628), a na phase 1 study. The primary outcome is Determination of Maximum Plasma Concentration [Cmax] of IRL757.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06699628 |
| Phase | Phase 1 |
| Condition | Not Applicable as This is a Mass Balance/Pharmacokinetic Study Performed in Healthy Subjects, Apathy |
| Allocation | Not applicable (single group) |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Integrative Research Laboratories AB |
| Results posted | Yes |
2. Clinical Question
Population
Healthy elderly volunteers enrolled in a Phase I pharmacokinetic study. The registry record lists an enrollment of 12.
Intervention
Single oral doses of IRL757 at two dose levels, described as lower and higher. The study evaluated ascending doses.
Comparator
The registry lists two IRL757 dose-level groups, with 6 participants at risk in each group for the reported adverse-event summaries. It does not describe a placebo or untreated control group. Allocation is listed as not applicable, and the study is not a randomized comparison.
Primary question
What is the maximum plasma concentration, or Cmax, of IRL757 after a single dose? The endpoint is specified in μmol/L, summarized as a geometric mean with geometric coefficient of variation, with pharmacokinetic follow-up until 48 hours.
This is a pharmacokinetic question: it concerns drug concentration in plasma after dosing, rather than whether a clinical symptom or condition changes. The record also lists safety observations, including adverse events, physical examination, electrocardiogram, vital signs, laboratory measurements, and C-SSRS findings.
The available record identifies the study question and selected safety counts, but provides no numerical Cmax result. It therefore does not allow a reader to describe the measured concentration, its variability, or how the two dose levels compare on the primary endpoint. Those results are not reported in the registry record.
3. Trial Design
The study is described as a single-centre, open-label, Phase I trial of single ascending oral doses of IRL757 in healthy elderly volunteers. The registry lists a parallel model and two groups: IRL757 Dose Level 1, described as a lower single dose, and IRL757 Dose Level 2, described as a higher single dose. Enrollment was 12, with 6 participants at risk in each group in the posted adverse-event summaries.
Open-label means that masking was not used, as reflected by the registry entry of NONE. Allocation is listed as NA. The record explicitly indicates that this is not a randomized comparison and that the arms should not be treated as a like-for-like control comparison. The groups are dose levels of the same drug, not an active treatment and a control arm. The record does not explain how participants were assigned to dose levels or whether any other procedures governed dose escalation.
The stated purpose is pharmacokinetic evaluation after single dosing. The primary endpoint is maximum plasma concentration, followed for pharmacokinetic purposes until 48 hours. The record also lists secondary safety outcomes covering adverse-event frequency, seriousness and intensity, and descriptions of physical examination, electrocardiogram, vital signs, safety laboratory, and C-SSRS findings.
The study is marked completed. The recorded start date is 2024-09-23 and the primary completion date is 2024-11-11. The registry lists 11 outcome measures and no analyses. It does not report a detailed statistical analysis plan, dose-escalation rules, eligibility criteria beyond the description of healthy elderly volunteers, or the rationale for the planned enrollment.
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.
Overall Study
| Stage | IRL757 Dose Level 1 | IRL757 Dose Level 2 |
|---|---|---|
| STARTED | 6 | 6 |
| COMPLETED | 6 | 6 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | IRL757 Dose Level 1 | IRL757 Dose Level 2 | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 6 | 12 | |
| Age, Continuous | years | 71.8 (SD 4.6) | 71.2 (SD 5.3) | 71.5 (SD 4.7) |
| Sex: Female, Male: Female | Participants | 3 | 5 | 8 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 6 | 6 | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 6 | 12 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Weight | kg | 77.42 (SD 13.6) | 68.2 (SD 10.95) | 72.81 (SD 12.72) |
6. Primary Endpoint
The registry lists the primary outcome as Determination of Maximum Plasma Concentration [Cmax] of IRL757, measured over PK followed until 48 hours.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | μmol/L |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum plasma concentration of IRL757, called Cmax, after a single dose. It represents the highest measured plasma concentration during the pharmacokinetic observation period. The registry specifies the unit μmol/L and follow-up until 48 hours. Cmax is commonly used in pharmacokinetic studies because it describes the peak concentration observed after dosing. As a concentration measure, it addresses drug exposure over the observation period, not a clinical benefit or change in apathy.
The record specifies a geometric mean and geometric coefficient of variation as the summary measures. In general, a geometric mean is useful for positive measurements that vary multiplicatively or have a right-skewed distribution. A geometric coefficient of variation describes relative dispersion on a multiplicative scale. These summaries can help characterize both the typical concentration and variability among participants without treating concentration differences as if they were necessarily additive.
The registry does not report the observed Cmax value, its geometric coefficient of variation, a confidence interval, or results by dose level. Thus, the endpoint definition is available, but its estimated value and precision are not reported in the registry record. No conclusion about the magnitude of plasma exposure or the relationship between dose level and Cmax can be drawn from the endpoint description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a small Phase I pharmacokinetic study with 12 participants and two IRL757 dose levels. Its primary question concerns Cmax after a single dose, with pharmacokinetic follow-up until 48 hours. The record specifies a geometric mean and geometric coefficient of variation, but gives no numerical result for either measure. It also provides no confidence interval or other estimate of uncertainty for Cmax. The size and precision of the primary endpoint estimate therefore cannot be evaluated from the registry record.
The study is not a randomized comparison, and the two arms are not a like-for-like control comparison. The groups are described as lower and higher IRL757 dose levels. Without numerical pharmacokinetic results, dose amounts, or details of assignment, the registry record does not establish how Cmax differed across dose levels or whether concentrations changed in a particular pattern. The dose descriptions alone do not show a dose-response relationship.
The safety summaries report no serious adverse events in either dose-level group and no deaths. The record reports other adverse events affecting 1 participant in Dose Level 1 and 2 participants in Dose Level 2. These counts describe the observed participants in this study; they do not quantify risks precisely, and they should not be interpreted as evidence that an event cannot occur. The record does not provide the event terms or further detail about severity and timing in the information.
In general, small studies provide limited information about uncommon outcomes and can yield imprecise estimates. A count of zero serious adverse events in a small group is compatible with uncertainty about the frequency of such events beyond the participants observed. Likewise, a difference in the number of participants with other adverse events between these groups cannot be interpreted as a causal dose effect in a nonrandomized study without additional design and analysis information.
The registry lists 11 outcome measures but no analyses. It does not provide a statistical analysis plan or a numerical primary endpoint result. Consequently, the findings that can be described are limited to the study design and the posted adverse-event counts; the primary pharmacokinetic result remains not reported in the registry record.
9. Statistical Methods Explained
What does Cmax measure?
Cmax is the maximum plasma concentration observed after a dose. It is a pharmacokinetic endpoint: it describes drug concentration in plasma, not a clinical outcome. The registry specifies that Cmax was evaluated after single dosing and that pharmacokinetic follow-up continued until 48 hours. The record does not state how often samples were collected, how the maximum was determined between sampling times, or how below-quantification measurements were handled.
Why use a geometric mean?
General explanation: Concentration measurements are positive and may vary in a multiplicative way. For data with that pattern, a geometric mean can describe a typical value more appropriately than an arithmetic mean. It is calculated using logarithms and then transformed back to the original scale. This summary does not imply that individual concentrations are identical or that the distribution is symmetric on the original scale. The registry specifies a geometric mean for Cmax, but does not report the estimated value.
What does geometric coefficient of variation describe?
General explanation: A coefficient of variation expresses variability relative to the scale of the measurements. Its geometric form is based on variation after logarithmic transformation and is suited to multiplicative variability. It helps indicate how dispersed individual values are around the geometric mean. It is not the same as a confidence interval: the coefficient describes variability among measurements, whereas a confidence interval describes uncertainty about an estimated population quantity. The registry names the geometric coefficient of variation but does not report its value.
What can a confidence interval add?
General explanation: A confidence interval gives a range of values compatible with the observed data under the statistical model used. A narrow interval indicates greater precision for the estimated quantity than a wide interval, though interpretation depends on the design and assumptions. No confidence interval for Cmax is reported in the registry record, so its precision cannot be assessed from the posted information.
How should the dose-level groups be understood?
The registry describes a parallel model with a lower and a higher single-dose group. It lists allocation as not applicable and states that this is not a randomized comparison. Thus, the group labels indicate dose levels, but the record does not establish exchangeability between groups or document how participants were assigned. In general, randomization can help balance other factors across groups; without a randomized comparison, observed group differences may reflect factors other than dose. The record does not provide numerical Cmax results by group in any case.
What does the adverse-event count represent?
The registry gives the number at risk and the number affected by serious and other adverse events in each dose-level group. These are descriptive safety counts. They are not a test of whether event frequencies differ between groups, and the record does not report an inferential comparison. In general, estimates from small groups are uncertain, especially for uncommon events. A zero count is an observation in the enrolled group, not proof that the event is impossible.
What is known about the analysis plan?
The registry lists no analyses. It does not report the statistical analysis plan, the analysis population for Cmax, handling of missing pharmacokinetic observations, or a sample-size justification. These details matter because they specify how endpoint values are selected, summarized, and interpreted. Their absence from the registry record does not establish what procedures were or were not conducted; it means those procedures cannot be described from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures, including the primary Cmax endpoint and secondary safety outcomes. It does not report a multiplicity strategy, such as a prespecified ordering of tests or an adjustment for making multiple statistical comparisons. The record lists no analyses, so it also does not identify which outcomes were formally tested, if any. Without that information, the family of inferential comparisons and the control of false-positive findings cannot be assessed.
Missing-data procedures are not reported in the registry record. The record does not explain how incomplete pharmacokinetic sampling, missing Cmax values, withdrawals, or unavailable safety observations were handled. It also does not specify the analysis population used for the primary endpoint or whether all enrolled participants contributed to each outcome. Enrollment was 12, but that does not by itself establish the number with evaluable pharmacokinetic measurements.
The registry does not report a statistical analysis plan or a sample-size justification. The absence of these details limits assessment of whether analyses were prespecified and how uncertainty was intended to be quantified. It should not be taken as proof that no planning or analysis occurred outside the registry record. The posted information is insufficient to determine the handling of multiplicity, missing observations, or analysis populations.
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 |
|---|---|---|---|
| IRL757 Dose Level 1 | 0 | 6 | 0.0% |
| IRL757 Dose Level 2 | 0 | 6 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IRL757 Dose Level 1 | 0 of 6 |
| IRL757 Dose Level 2 | 0 of 6 |
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 |
|---|---|
| IRL757 Dose Level 1 | 1 of 6 |
| IRL757 Dose Level 2 | 2 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | IRL757 Dose Level 1 | IRL757 Dose Level 2 |
|---|---|---|---|
| Headache | Nervous system disorders | 0 of 6 | 2 of 6 |
| Nasopharyngitis | Infections and infestations | 0 of 6 | 1 of 6 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 6 | 0 of 6 |
The posted safety counts list 6 participants at risk in each dose-level group. No serious adverse events were reported in either group, and no deaths were reported. Other adverse events were reported for 1 participant in Dose Level 1 and 2 participants in Dose Level 2.
These figures are descriptive counts from this study. They do not show that a dose level caused an event, and they are not a randomized comparison. The groups are described as lower and higher IRL757 dose levels, but the registry does not report an inferential safety analysis. The event terms and additional details about timing and intensity are not reported in the registry record.
General explanation: A zero count means no event of that category was observed among the participants at risk in that group during the recorded observation. It does not establish that the event cannot occur or precisely estimate how often it might occur in a broader population. Small groups are especially limited for assessing uncommon harms. The safety counts should therefore be read as observations within this trial, not as definitive estimates of risk.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed Phase I study designed to evaluate the pharmacokinetics of single ascending oral doses of IRL757 in healthy elderly volunteers. It identifies Cmax as the primary endpoint and specifies a geometric mean, geometric coefficient of variation, and follow-up until 48 hours. These details show what the study set out to measure, but not what Cmax was.
The numerical primary endpoint result is not reported in the registry record. There is no posted Cmax estimate, measure of dispersion, confidence interval, or group-specific result in the information available. Consequently, the record does not support a quantitative description of plasma exposure or a conclusion about how exposure varied across the two dose levels.
The available safety counts report no serious adverse events and no deaths, with other adverse events affecting 1 participant in Dose Level 1 and 2 participants in Dose Level 2. Those observations describe this small study only. They do not establish the absence of risk or a causal difference between dose groups. The design is not a randomized comparison and does not include a like-for-like control group.
This study is not an efficacy trial in the information recorded. Although apathy appears among the listed conditions, the primary endpoint is pharmacokinetic, and the record does not present a clinical efficacy result. The listed safety outcomes are also not accompanied by detailed numerical findings beyond the adverse-event counts. The study therefore contributes a defined pharmacokinetic question and limited posted safety observations, while leaving the primary numerical result and broader clinical implications not reported in the registry record.
13. Why This Trial Matters Statistically
Early pharmacokinetic studies address how a drug appears in plasma after dosing. Cmax is one way to characterize peak exposure, and describing its central value and variability can inform interpretation of concentration measurements. The registry’s choice of a geometric mean and geometric coefficient of variation is consistent with summarizing positive measurements that may vary multiplicatively. The numerical estimates are not reported, however, so the intended statistical summaries cannot be examined in practice from this record.
The study also illustrates the distinction between a dose-level study and a controlled treatment comparison. The two groups received different described dose levels of IRL757; the registry does not identify a randomized control group. This design description matters when interpreting any apparent difference between groups: group differences alone would not establish that dose caused the difference. In this record, the primary pharmacokinetic results needed for such a comparison are absent.
The safety counts offer a concise description of observed serious and other adverse events, but the limited enrollment means the record cannot characterize uncommon events precisely. A zero serious-event count is informative as an observation in the study, while remaining limited evidence about events that may occur infrequently.
For biostatistical interpretation, the record is a reminder to separate endpoint definition from endpoint result, and descriptive counts from comparative evidence. It provides clear study-purpose and design information, but the statistical analysis details and primary endpoint estimates are not reported. This distinction prevents study rationale or endpoint labels from being mistaken for evidence about the magnitude or precision of the measured pharmacokinetic response.
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 the primary question is that no numerical Cmax result is reported in the registry record. The specified unit, geometric summary, dispersion measure, and follow-up period define the endpoint, but do not reveal its observed magnitude or precision. No confidence interval or numerical result by dose level is reported.
Enrollment was 12, and the posted safety groups each list 6 participants at risk. This is a small study for describing variability or uncommon safety events. The registry does not provide a sample-size justification, so the rationale for enrollment and the precision intended for the pharmacokinetic estimate are not reported in the registry record.
The design is open-label and not randomized, with no like-for-like control comparison. The record does not detail assignment procedures, dose amounts, or dose-escalation rules. It also does not provide a statistical analysis plan, missing-data procedures, analysis populations, or multiplicity methods. These omissions limit evaluation of how results were intended to be calculated and interpreted.
Although the registry lists secondary safety outcomes, detailed results for physical examinations, electrocardiograms, vital signs, laboratory measurements, and C-SSRS findings are not reported in the registry record. The adverse-event summaries do not provide event terms or detailed timing and intensity information. These limitations are specific to the information recorded and do not establish what may be available outside the registry.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase I Trial Evaluating the Pharmacokinetics of Single Ascending Oral Doses of IRL757 in Healthy Elderly Volunteers — NCT06699628.
- Registry record last updated 2026-02-05; status last verified 2026-01.
- Results first posted 2026-02-05.
- 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
NCT06699628 is a completed, single-centre, open-label, Phase I parallel study of single ascending oral doses of IRL757 in healthy elderly volunteers. The registry lists enrollment of 12, with lower- and higher-dose groups. The primary endpoint is maximum plasma concentration, summarized as a geometric mean with geometric coefficient of variation and followed for pharmacokinetic purposes until 48 hours.
The registry reports no numerical primary endpoint result and lists no analyses. For safety, it reports no serious adverse events and no deaths; other adverse events affected 1 participant in Dose Level 1 and 2 participants in Dose Level 2. The study is not a randomized comparison, and the arms are not a like-for-like control comparison. Detailed statistical planning and analysis procedures are not reported in the registry record.