Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

Phase 1

Completed

• Conditions: Opioid-Related Disorders; Hepatitis C
• Interventions: Drug: telaprevir; Drug: buprenorphine/naloxone

• Registration Number: NCT01275599
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose adjustments are necessary for patients who are concomitantly treated with telaprevir.

Telaprevir, in combination with other antiviral agents, is being investigated for the treatment of chronic hepatitis C virus infection. Buprenorphine/naloxone is used for maintainance therapy in patients with opioid dependence.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Primary Completion: 2011-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Males or females between the ages of 18 and 64 years, inclusive. Females must be of non-childbearing potential.
• Receiving once daily buprenorphine/naloxone maintenance therapy at a stable dose not exceeding 24 mg/6 mg, respectively, for at least 2 weeks prior to screening.

Exclusion Criteria

• Illicit use of drugs such as cocaine, amphetamines and methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines, tricyclic antidepressants, methadone or opiates/opioids (apart from buprenorphine).
• Treatment with any investigational drug within the last 30 days, or 5 half-lives, whichever is longer.
• Blood donation of 500 mL or more within the last 56 days.
• Infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Arm	telaprevir	The treatment period will include 3 phases: * 14 day run-in period * 7 day co-administration period * 31 day follow-up period
Open-Label Arm	buprenorphine/naloxone	The treatment period will include 3 phases: * 14 day run-in period * 7 day co-administration period * 31 day follow-up period

Primary Outcome Measures

Name	Time	Method
Blood levels of telaprevir	Day 1 through Day 7	Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Blood levels of buprenorphine	Day -4 through Day 38	Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Blood levels of norbuprenorphine	Day -4 through Day 38	Measured by maximum observed concentration (Cmax), minimum observed concentration (Cmin), time of the maximum concentration (tmax), area under the time curve (AUC) from the time of study drug administration, zero to tau, where tau is the dosing interval.
Blood levels of naloxone	Day -1 and Day 7	Measured by maximum observed concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	Day -14 through Day 38	Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs.
Buprenorphine withdrawal symtoms	Day -2 through Day 38	Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.