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 Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers (NCT01371006), a non-randomized phase 1 study. The primary outcome is Group A - Efavirenz: Cmax.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01371006 |
| Phase | Phase 1 |
| Condition | Healthy |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boehringer Ingelheim |
| Results posted | Yes |
2. Clinical Question
Population
Healthy volunteers were enrolled, with 29 participants reported overall. The primary endpoint population was subjects entered in sequence group A who were part of the pharmacokinetic set. That set included treated subjects with evaluable data for at least one observation for at least one primary pharmacokinetic endpoint in any trial period, provided they had no important protocol violations.
Intervention
The study was designed to obtain interaction data between BI 201335 and Efavirenz, and to examine Midazolam as a CYP3A4 probe in relation to enzyme induction and inhibition. The registry describes group A as involving Faldaprevir and Efavirenz, and group B as involving Faldaprevir and Midazolam, with an additional group B condition including Efavirenz.
Comparator
This was a non-randomized, parallel study with no masking. The registry lists conditions and treatment combinations, but does not establish a randomized, like-for-like control comparison. A specific comparator for interpreting the primary endpoint is not reported in the registry record.
Primary question
The primary endpoint was the maximum plasma concentration, or Cmax, of Efavirenz in sequence group A. The registry describes that group as receiving 240 mg Faldaprevir plus 50 mg Efavirenz. The question was to characterize Efavirenz exposure in this setting; the numerical Cmax result and a comparative estimate are not reported in the registry record.
The study’s broader purpose was to obtain interaction information that could guide dosing when BI 201335 and Efavirenz are administered together. The registry also describes using Midazolam as a CYP3A4 probe to predict an interaction involving the enzyme and the study drugs. These are pharmacokinetic and metabolism questions, rather than questions about clinical benefit.
The record uses BI 201335 in the study title and Faldaprevir in the primary endpoint description and outcome labels. It does not explain that naming difference. Accordingly, the endpoint should be described using the label in its own definition: Efavirenz Cmax in group A, described as 240 mg Faldaprevir plus 50 mg Efavirenz. The record does not report a numerical endpoint value, a confidence interval, or a test of a group difference.
3. Trial Design
This completed phase 1 study enrolled 29 healthy volunteers. It used a non-randomized allocation, a parallel model and no masking. Those design features matter when reading any treatment-group contrast: the record does not describe random assignment to groups, so treatment groups cannot automatically be treated as exchangeable. The registry itself cautions that the arms are not a like-for-like control comparison.
The study’s stated aim was to obtain interaction data between BI 201335 and Efavirenz, and to investigate CYP3A4 metabolism using Midazolam as a probe. The registry describes Efavirenz as an enzyme inducer and BI 201335 as an enzyme inhibitor in its brief summary. It lists three drug interventions using the labels “low dose,” “normal dose” and “low dose,” while arm descriptions identify low-dose Efavirenz and normal-dose Efavirenz. The complete treatment sequence and dosing schedule for every group are not reported in the registry record.
Outcome labels distinguish group A and group B. Group A includes Efavirenz and Faldaprevir outcomes, including Cmax, Tmax, AUC0-12h,ss and C12,ss. Group B includes Faldaprevir and Midazolam outcomes, including Midazolam Cmax and Tmax. Additional group B outcomes are listed for Faldaprevir with Midazolam and for Faldaprevir, Midazolam and Efavirenz together. The record lists 17 outcome measures and 5 analyses, but the full analysis plan is not reported in the registry record.
The primary endpoint was Efavirenz Cmax in group A, assessed at scheduled times extending from 0:00 through 144:00 hours after Efavirenz administration. The registry defines the endpoint population as members of the pharmacokinetic set who entered sequence group A. The study dates are listed as 2011-06 for start and 2011-09 for primary completion, and the status is completed. Further details about sequence allocation, dosing periods, washout, or the rationale for the design are not reported in the registry record.
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 | Group A: 240 mg Faldaprevir+50 mg Efavirenz | Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam |
|---|---|---|
| STARTED | 14 | 15 |
| COMPLETED | 13 | 15 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | Group A: 240 mg Faldaprevir+50 mg Efavirenz | Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam |
|---|---|---|
| Adverse Event | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.
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 | Group A: 240 mg Faldaprevir+50 mg Efavirenz | Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam | Total |
|---|---|---|---|---|
| Participants analysed | 14 | 15 | 29 | |
| Age, Continuous | years | 39.4 (SD 10.7) | 33.1 (SD 11.6) | 36.1 (SD 11.5) |
| Sex: Female, Male: Female | Participants | 8 | 6 | 14 |
| Sex: Female, Male: Male | Participants | 6 | 9 | 15 |
6. Primary Endpoint
The registry lists the primary outcome as Group A - Efavirenz: Cmax, measured over 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nmol/L |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum plasma concentration, or Cmax, of Efavirenz in sequence group A. It describes the highest measured concentration of the drug in plasma over the stated pharmacokinetic assessment period. The registry reports the unit as nmol/L and specifies that the endpoint is summarized as a geometric mean with geometric coefficient of variation as the dispersion measure.
Cmax is used in pharmacokinetic studies because it characterizes peak exposure. In a drug-interaction study, concentration measures can help describe whether exposure differs across treatment conditions. That general role does not establish that any particular interaction occurred: interpretation requires the actual concentration summaries and, for a comparison, an appropriate contrast and its uncertainty. The numerical Cmax, geometric coefficient of variation, and comparative estimate are not reported in the registry record.
The endpoint timeframe lists scheduled measurements at 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 and 144:00 hours after Efavirenz administration. Those are assessment times, not separate primary endpoints. The endpoint description specifies group A as 240 mg Faldaprevir plus 50 mg Efavirenz. Although the study title uses BI 201335, the record does not explain the difference between that name and Faldaprevir in the endpoint description.
The geometric mean is a measure of central tendency often used for pharmacokinetic concentrations, which can be right-skewed. The geometric coefficient of variation describes relative spread on a multiplicative scale. These summaries do not, by themselves, show a treatment effect or its precision. A confidence interval for the endpoint or a contrast is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary question as measurement of Efavirenz Cmax in group A, but it does not report the endpoint’s numerical result. Consequently, the concentration level, its variability and any difference between treatment conditions cannot be described from the posted registry information. No confidence interval or p-value for this endpoint is reported in the registry record. The study’s stated aims describe the questions under investigation, not the findings.
The design is non-randomized and parallel, and the arms are not a like-for-like control comparison. A contrast between groups in such a study may reflect differences in group membership or other design features as well as treatment conditions. Random allocation is one way to support comparability; it is absent. The record does not provide enough detail to determine how the groups were formed or how potential imbalances were handled.
The primary endpoint is a pharmacokinetic concentration summary rather than a clinical outcome. Cmax is relevant to peak exposure, while other listed outcomes address additional aspects of concentration and timing, including Tmax, AUC0-12h,ss and C12,ss. Without reported values, however, it is not possible to characterize either the magnitude or direction of a concentration pattern. Nor can the title or stated objective be treated as evidence of an interaction’s size.
The record lists 17 outcome measures and 5 analyses. It does not report the detailed statistical methods, whether analyses were adjusted for multiple comparisons, or how estimates were selected for reporting. A multiplicity approach is therefore not reported in the registry record. Similarly, the record’s description of a pharmacokinetic set gives eligibility criteria, but does not state how many participants contributed to the primary endpoint or how missing observations were handled.
Safety entries report no serious events among the listed participants at risk in the treatment groups. Other adverse events are also tabulated by group, but event counts alone do not establish comparative risk, especially in a small study without randomized, like-for-like groups. Death counts are not reported in the registry record. The safety information should be read as descriptive reporting for this study, not as a definitive comparison.
A planning illustration may be based on an observed effect, but it is not observed power. In this case, the registry’s numerical primary result is not reported, so the effect magnitude and numerical planning outputs cannot be assessed from the record. Any calculated sample-size scenarios are planning illustrations under stated assumptions, not evidence about the trial’s actual probability of detecting an effect.
9. Statistical Methods Explained
What does the primary summary measure?
The primary endpoint is Efavirenz Cmax, expressed in nmol/L and summarized as a geometric mean with geometric coefficient of variation. Cmax represents the maximum plasma concentration over the scheduled assessment period. In general, pharmacokinetic concentrations can be skewed, and a geometric summary can be useful when values vary multiplicatively rather than additively. The geometric coefficient of variation describes relative dispersion on that scale. Neither summary provides a treatment contrast by itself. The numerical summaries are not reported in the registry record.
What would an uncertainty interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under a specified statistical model. For a treatment contrast, it can show which effect sizes remain compatible with the data and model. It is distinct from a p-value, which addresses evidence against a specified null hypothesis under its assumptions. The registry record does not report a confidence interval or p-value for the primary endpoint, nor does it describe the model used to estimate a contrast. Therefore, precision and inferential strength cannot be evaluated from the posted primary outcome information.
Why does allocation matter?
Randomization can help balance measured and unmeasured characteristics across treatment groups, on average. This study is listed as non-randomized, with parallel groups and no masking. Its own record warns that the arms are not a like-for-like control comparison. As a general principle, a between-group difference in a non-randomized study can be entangled with differences in group composition, treatment assignment processes or other factors. The registry does not report adjustment methods or sufficient detail to determine how such differences were addressed.
What is the pharmacokinetic set?
The primary endpoint population is defined as all subjects entered in sequence group A who were in the pharmacokinetic set. The set includes treated subjects with evaluable data for at least one observation for at least one primary pharmacokinetic endpoint in any trial period, without important protocol violations. This definition indicates that endpoint analysis was not necessarily based on every enrolled person. The number included in the primary analysis, exclusions by reason and the handling of missing observations are not reported in the registry record.
How should multiple outcomes be considered?
The record lists 17 outcome measures and 5 analyses. In general, examining multiple outcomes or contrasts can increase the chance that at least one result appears notable by chance if each is assessed separately. Methods such as prespecifying a primary outcome, adjusting significance thresholds or organizing analyses hierarchically can address that issue, but the registry record does not state whether any such method was used. It also does not provide a complete statistical analysis plan. No multiplicity adjustment should be assumed.
What do the planning illustrations mean?
The sample-size assumptions describe planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. They describe detecting a stated fraction of the observed effect. For time-to-event outcomes, the stated convention is total events; for other outcomes, it is participants per arm. These are planning assumptions, not observed trial findings and not observed power. Because the numerical effect and numerical planning outputs are not reported in the registry record, their practical implications cannot be assessed from the registry information.
Why might over-dispersion matter in general?
Over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model underestimates variability, its uncertainty estimates may be too narrow and its inferential results too optimistic. Models can account for extra variability when appropriate, but choosing a method requires knowledge of the data structure and analysis plan. The primary outcome is a geometric summary of concentration, and the record does not report a model or an over-dispersion assessment. This general concept should not be taken to imply that over-dispersion was present in this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures and 5 analyses. The primary outcome is Efavirenz Cmax in group A, but several additional pharmacokinetic measures are listed for group A and group B, including Tmax, AUC0-12h,ss, C12,ss and Midazolam Cmax. When many outcomes or contrasts are examined, the chance of at least one apparently unusual result can increase. In general, a prespecified testing hierarchy or multiplicity adjustment can address this concern. Whether either was used is not reported in the registry record.
The record does not provide a full statistical analysis plan, so it is not possible to identify which analyses were confirmatory, which were exploratory, or how the reported analyses related to the listed outcomes. The number of analyses alone does not establish that every outcome was tested in the same way. No adjustment method or adjusted inferential result is reported in the registry record.
The primary endpoint population is restricted to subjects entered in sequence group A who were included in the pharmacokinetic set. That set comprises treated subjects with evaluable data for at least one observation for at least one primary pharmacokinetic endpoint in any trial period, without important protocol violations. This definition does not give the number analyzed for the primary endpoint, the number excluded, or the reasons for exclusion. The registry record does not report how missing concentration observations were handled, whether any imputation was used, or whether a sensitivity analysis assessed missing data.
Because these details are absent, readers cannot determine whether analysis populations and missing-data procedures could have affected the reported estimates. The population definition describes eligibility for the PK set; it does not substitute for reporting participant flow, endpoint-specific denominators or missingness patterns.
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 |
|---|---|---|---|
| Group A: Efavirenz | 0 | 14 | 0.0% |
| Group A: Faldaprevir | 0 | 14 | 0.0% |
| Group A: Faldaprevir+Efavirenz | 0 | 13 | 0.0% |
| Group B: Midazolam | 0 | 15 | 0.0% |
| Group B: Faldaprevir | 0 | 15 | 0.0% |
| Group B: Faldaprevir+Midazolam | 0 | 15 | 0.0% |
| Group B: Faldaprevir+Midazolam+Efavirenz | 0 | 15 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Group A: Efavirenz | 3 of 14 |
| Group A: Faldaprevir | 13 of 14 |
| Group A: Faldaprevir+Efavirenz | 11 of 13 |
| Group B: Midazolam | 1 of 15 |
| Group B: Faldaprevir | 14 of 15 |
| Group B: Faldaprevir+Midazolam | 6 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Group A: Efavirenz | Group A: Faldaprevir | Group A: Faldaprevir+Efavirenz | Group B: Midazolam | Group B: Faldaprevir | Group B: Faldaprevir+Midazolam |
|---|---|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 1 of 14 | 6 of 14 | 3 of 13 | 0 of 15 | 6 of 15 | 1 of 15 |
| Headache | Nervous system disorders | 2 of 14 | 3 of 14 | 5 of 13 | 0 of 15 | 3 of 15 | 0 of 15 |
| Diarrhoea | Gastrointestinal disorders | 1 of 14 | 5 of 14 | 2 of 13 | 1 of 15 | 2 of 15 | 1 of 15 |
| Ocular icterus | Eye disorders | 0 of 14 | 4 of 14 | 0 of 13 | 0 of 15 | 5 of 15 | 1 of 15 |
| Dizziness | Nervous system disorders | 0 of 14 | 3 of 14 | 0 of 13 | 0 of 15 | 4 of 15 | 0 of 15 |
| Jaundice | Hepatobiliary disorders | 0 of 14 | 0 of 14 | 1 of 13 | 0 of 15 | 6 of 15 | 0 of 15 |
| Vomiting | Gastrointestinal disorders | 0 of 14 | 3 of 14 | 0 of 13 | 0 of 15 | 2 of 15 | 0 of 15 |
| Sunburn | Injury, poisoning and procedural complications | 0 of 14 | 0 of 14 | 4 of 13 | 0 of 15 | 1 of 15 | 0 of 15 |
| Dyspepsia | Gastrointestinal disorders | 0 of 14 | 2 of 14 | 1 of 13 | 0 of 15 | 0 of 15 | 0 of 15 |
| Sleep disorder | Psychiatric disorders | 0 of 14 | 0 of 14 | 0 of 13 | 0 of 15 | 2 of 15 | 0 of 15 |
The safety record presents serious adverse events and other adverse events separately for each listed treatment group. It reports zero serious events among the participants at risk in each group: 14 for Group A: Efavirenz, 14 for Group A: Faldaprevir, 13 for Group A: Faldaprevir+Efavirenz, 15 for Group B: Midazolam, 15 for Group B: Faldaprevir, 15 for Group B: Faldaprevir+Midazolam, and 15 for Group B: Faldaprevir+Midazolam+Efavirenz. No serious-event terms are listed.
Other adverse events were reported for 3 participants in Group A: Efavirenz, 13 in Group A: Faldaprevir, 11 in Group A: Faldaprevir+Efavirenz, 1 in Group B: Midazolam, 14 in Group B: Faldaprevir, 6 in Group B: Faldaprevir+Midazolam and 15 in Group B: Faldaprevir+Midazolam+Efavirenz. These are counts of participants affected, not event rates or estimates of a causal treatment effect. The groups are non-randomized and are not a like-for-like control comparison.
Death counts are not reported in the registry record; a missing death value should not be interpreted as a reported count of zero. The safety entries are descriptive, and the small group sizes limit how much can be inferred from an absence of reported serious events.
12. What the Result Does, and Does Not, Mean
This study addresses pharmacokinetic interaction questions in healthy volunteers. Its primary endpoint is Efavirenz Cmax in group A, and its broader aims concern BI 201335, Efavirenz and CYP3A4 metabolism using Midazolam as a probe. The registry record documents those questions and identifies several pharmacokinetic outcomes. It does not report the numerical result for the primary endpoint, so the direction, size and precision of any observed concentration pattern cannot be stated.
The study’s design also limits what a treatment contrast can establish. Allocation was non-randomized, the model was parallel, and the record specifically cautions that the arms are not a like-for-like control comparison. Thus, even if group values were available, differences would need to be interpreted in light of potential baseline or assignment differences. The registry does not describe a statistical adjustment strategy that would resolve those concerns.
A concentration endpoint is not the same as a clinical outcome. In general, pharmacokinetic data describe drug exposure, and they may inform questions about dosing or metabolism. They do not by themselves establish clinical benefit, clinical harm or the consequences of a particular exposure. The record’s stated intention to guide dosing is an objective, not a reported conclusion.
The safety summaries report no serious adverse events in the listed groups, alongside counts of participants with other adverse events. These descriptive counts do not establish that treatments are equivalent or that any combination is safer than another. Death counts are not reported in the registry record.
Finally, the study’s small overall enrollment and the absence of numerical primary outcome results prevent an assessment of effect precision. The record does not report confidence intervals, p-values or the detailed statistical analysis plan. Conclusions should therefore remain limited to the design, endpoint definitions and descriptive safety entries that the registry records.
13. Why This Trial Matters Statistically
Drug-interaction questions often depend on how one treatment changes the exposure of another, and pharmacokinetic measures provide a structured way to describe that exposure. This study’s primary focus on Efavirenz Cmax and its other listed concentration and timing measures illustrates how a phase 1 investigation can examine exposure and metabolism rather than clinical outcomes.
The study is also a useful example of why design labels matter. It is non-randomized and parallel, and the record explicitly warns that its arms are not a like-for-like control comparison. That caution is central to interpretation: observed group patterns, if reported, would not automatically isolate a treatment effect. Statistical summaries cannot remove design limitations unless appropriate information and methods are available.
The outcome list spans several measures and treatment combinations, while the record reports 17 outcome measures and 5 analyses. This makes transparency about prespecification and multiplicity relevant. The registry does not report whether multiple testing was addressed or provide a complete analysis plan. Those omissions make it difficult to distinguish confirmatory findings from exploratory descriptions.
The record further defines a pharmacokinetic analysis set but does not report endpoint-specific participant counts or missing-data handling. These details matter because exclusion or missing observations can affect both the represented population and uncertainty. The set definition is useful, but it is not a substitute for reporting participant flow and analysis denominators.
Finally, a study objective and a planned endpoint are not results. With no numerical primary Cmax value or inferential estimate reported in the registry, the record supports describing the question and design, but not quantifying the interaction. That distinction is important for interpreting pharmacokinetic trials carefully and avoiding conclusions beyond the posted evidence.
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 key limitation for statistical interpretation is that the registry record does not report numerical results for the primary Efavirenz Cmax endpoint. It also does not report a confidence interval, p-value or comparative estimate. The magnitude and precision of the primary finding therefore cannot be assessed from the registry record.
Allocation was non-randomized, masking was absent, and the study used a parallel model. The record warns that the arms are not a like-for-like control comparison. Group differences could therefore be influenced by how participants entered the groups or by differences in their characteristics. The group formation process and any methods to adjust for imbalances are not reported in the registry record.
The record identifies 17 outcome measures and 5 analyses but does not report a full analysis plan or a multiplicity strategy. It is not possible to determine which outcomes were prespecified for confirmatory interpretation or how multiple analyses were accounted for. Endpoint-specific sample sizes, participant flow and reasons for exclusions are also not reported. Although the pharmacokinetic set has a stated eligibility definition, the number contributing to the primary endpoint is not given.
Missing-data methods are not reported in the registry record. It is therefore unclear how incomplete concentration profiles or unevaluable observations were handled, and no sensitivity analysis is described. This matters because the primary endpoint depends on measured concentrations over scheduled times.
The study enrolled healthy volunteers, and the record does not establish how its findings would apply to other populations. The record also uses BI 201335 in the title but Faldaprevir in the primary endpoint description without explaining the naming difference. Finally, the registry does not report death counts, so no conclusion about deaths can be drawn from that field.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the Effect of Multiple Dosing With BI 201335 on CYP2B6 Metabolism and Effect of Multiple Dosing With Efavirenz on the Steady-state Pharmacokinetics of BI 201335 and on CYP3A4/5 Metabolism in Healthy Volunteers — NCT01371006.
- Registry record last updated 2015-08-03; status last verified 2015-07.
- Results first posted 2015-08-03.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01371006 is a completed phase 1 study sponsored by Boehringer Ingelheim, with 29 healthy volunteers reported. It used non-randomized allocation, a parallel model and no masking. Its stated purpose was to obtain interaction data between BI 201335 and Efavirenz and to investigate CYP3A4 metabolism using Midazolam as a probe.
The primary endpoint was Efavirenz Cmax in sequence group A, summarized as a geometric mean with geometric coefficient of variation and measured in nmol/L. Its numerical result is not reported in the registry record. The record lists 17 outcome measures and 5 analyses, but does not report a complete statistical analysis plan, multiplicity method or missing-data procedure.
The listed groups report zero serious adverse events; other adverse-event counts vary by group. Death counts are not reported in the registry record. The registry cautions that the non-randomized arms are not a like-for-like control comparison, an important limitation for interpreting any between-group difference.