Phase 1
N=34
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01637922 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. — 6990; 5920 [ng*h/mL] — p=0.1638
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 201335 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. |
6990; 5920 | 0.1638 |
| PRIMARY R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. |
393; 345 | 0.0391 sig |
| PRIMARY R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. |
235; 210 | 0.0603 |
| PRIMARY S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9 |
7610; 6470 | 0.1424 |
| PRIMARY S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9 |
474; 425 | 0.0367 sig |
| PRIMARY S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9 |
231; 207 | 0.0488 sig |
| PRIMARY Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. |
58700; 54000 | 0.1642 |
| PRIMARY Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. |
7610; 8240 | 0.1420 |
| PRIMARY Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. |
1110; 904 | 0.1915 |
| PRIMARY Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. |
59200; 42900 | 0.6889 |
| PRIMARY Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. |
3690; 2770 | 0.6188 |
| PRIMARY Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. |
2080; 2010 | 0.3152 |
| PRIMARY Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9. |
971; 1000 | 0.0107 sig |
| PRIMARY Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9. |
284; 357 | 0.0738 |
| PRIMARY Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9. |
23.4; 25.6 | — |
| SECONDARY Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline |
0.0; -1.0; 0.0; 0.0; 0.0; 0.0 | — |
Summary
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.
Eligibility Criteria
Inclusion criteria
- stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy.
- Male and female volunteers with a body mass index (BMI) = 18.5 and 470.
- use of any other investigational drug within 30 days of the study.
- drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone)
- blood donation of more than 100mL within four weeks of the trial.
- excessive physical activities one week prior to and during the trial.
- any clinically relevant laboratory value.
- concomitant use of any food product known to alter P450 or P-gp activity such as grapefruit juice, seville oranges and St. John's Wort.
- inadequate venous access
For women of childbearing potential:
- pregnancy or planning to become pregnant within 3 months of the trial
- positive pregnancy test at screening visit
- no proof of sterilization or unwilling or unable to use a double barrier method of birth control during the study and up to 3 months after the study.
- lactation with active breastfeeding from screening up to 30 days after last study visit.
Data sourced from ClinicalTrials.gov (NCT01637922). 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.