Phase 1
N=29
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
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01371006 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Group A - Efavirenz: Cmax — 771.0; 809.0 nmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- low dose (Drug); normal dose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Group A - Efavirenz: Cmax |
771.0; 809.0 | — |
| PRIMARY Group A - Efavirenz: AUC0-∞ |
36100.0; 40700.0 | — |
| PRIMARY Group B - Faldaprevir: Cmax,ss |
24000.0; 17200.0 | — |
| PRIMARY Group B - Faldaprevir: AUC0-12h,ss |
225000.0; 146000.0 | — |
| PRIMARY Group B - Faldaprevir: C12,ss |
14700.0; 7650.0 | — |
| SECONDARY Group A - Faldaprevir: Cmax,ss |
34600.0 | — |
| SECONDARY Group A - Faldaprevir: Tmax,ss |
3.00 | — |
| SECONDARY Group A - Faldaprevir: AUC0-12h,ss |
341000 | — |
| SECONDARY Group A - Faldaprevir: C12,ss |
23900 | — |
| SECONDARY Group A - Efavirenz: Tmax |
3.00; 3.03 | — |
| SECONDARY Group B - Faldaprevir: Tmax,ss |
3.00; 2.02 | — |
| SECONDARY Group B - Midazolam: Cmax |
110.0; 121.0; 44.9 | — |
| SECONDARY Group B - Midazolam: Tmax |
1.00; 1.00; 0.74 | — |
| SECONDARY Group B - Midazolam: AUC0-∞ |
278; 624; 110 | — |
| SECONDARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG |
1; 0; 0; 1 | — |
| SECONDARY Group A - Number of Participants With Drug Related Adverse Events |
2; 13; 11; 13 | — |
| SECONDARY Group B - Number of Participants With Drug Related Adverse Events |
1; 14; 3; 14; 15 | — |
Summary
Obtain interaction data between BI 201335 and Efavirenz to guide dosing for each drug when administered together.
To predict drug interaction between BI 201335 and Cyp 3A4 y using Midazolam as cyp 3A4 probe , Efavirenz as enzyme inducer and BI 201335 as enzyme inhibitor.
Eligibility Criteria
Inclusion criteria
Healthy volunteers age 18- 55 BMI (Body Mass Index) 18.5 - 29.9
Exclusion criteria
- Any finding on medical examination and ECG (Electrocardiography) deviating from normal
- Active diseases
- History of photosensitivity or rash
Data sourced from ClinicalTrials.gov (NCT01371006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.