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Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01275599
Collaborator
Tibotec BVBA (Industry)
16
Enrollment
2
Locations
1
Arm
8
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Single-Sequence Study to Examine the Effect of Telaprevir on the Pharmacokinetics of Buprenorphine in Subjects on Stable Buprenorphine/Naloxone Maintenance Therapy
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open-Label Arm

The treatment period will include 3 phases: 14 day run-in period 7 day co-administration period 31 day follow-up period

Drug: telaprevir
Two 375 mg tablets administered every 8 hours on Day 1 through Day 7, inclusive.

Drug: buprenorphine/naloxone
Buprenorphine/naloxone sublingual tablets or films contain buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine:naloxone (ratio of free bases). In this study buprenorphine/naloxone will be dosed from Day -14 through Day 38, inclusive. From Day -14 through Day -1 all subjects will receive a maximum of 24 mg/6 mg of buprenorphine/naloxone. Subjects will not be permitted to change their dose during the telaprevir co-administration period (Day 1 through Day 7) unless warranted by the investigator's clinical judgment of subject safety. After Day 8, the dose of buprenorphine/naloxone may be adjusted if deemed necessary by the investigator.
Other Names:
  • Suboxone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. Blood levels of naloxone [Day -1 and Day 7]

      Measured by maximum observed concentration (Cmax)

    4. 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.

    Secondary Outcome Measures

    1. Safety and tolerability [Day -14 through Day 38]

      Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs.

    2. Buprenorphine withdrawal symtoms [Day -2 through Day 38]

      Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Overland Park Kansas United States
    2 Salt Lake City Utah United States

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated
    • Tibotec BVBA

    Investigators

    • Study Director: Scott McCallister, M.D., Vertex Pharmaceuticals Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01275599
    Other Study ID Numbers:
    • VX10-950-024
    First Posted:
    Jan 12, 2011
    Last Update Posted:
    Jun 8, 2011
    Last Verified:
    Jun 1, 2011
    Additional relevant MeSH terms:
    Hepatitis C
    Opioid-Related Disorders
    Buprenorphine
    Buprenorphine, Naloxone Drug Combination
    Naloxone

    Study Results

    No Results Posted as of Jun 8, 2011