Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: BI 201335

• Registration Number: NCT01637922
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-11
• Study Start: 2012-08
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone group	BI 201335	patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day
Buprenorphine	BI 201335	patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.

Primary Outcome Measures

Name	Time	Method
R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose
Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.
Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.
Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.	0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9	These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline	Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment	The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.
Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline	Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment	The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times \[c.f. Section 3.1\]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.

Trial Locations

Locations (3)

1220.57.0001 Boehringer Ingelheim Investigational Site; 🇺🇸 Atlanta, Georgia, United States

1220.57.0003 Boehringer Ingelheim Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

1220.57.0002 Boehringer Ingelheim Investigational Site; 🇺🇸 Overland Park, Kansas, United States