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Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

This study has been completed.
Sponsor:
Collaborator:
Tibotec BVBA
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01275599
First received: January 11, 2011
Last updated: June 7, 2011
Last verified: June 2011
History of Changes

January 11, 2011
June 7, 2011
January 2011
April 2011   (final data collection date for primary outcome measure)
  • Blood levels of buprenorphine [ Time Frame: Day -4 through Day 38 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day -4 through Day 38 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day -1 and Day 7 ] [ Designated as safety issue: No ]
    Measured by maximum observed concentration (Cmax)
  • Blood levels of telaprevir [ Time Frame: Day 1 through Day 7 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01275599 on ClinicalTrials.gov Archive Site
  • Safety and tolerability [ Time Frame: Day -14 through Day 38 ] [ Designated as safety issue: Yes ]
    Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs.
  • Buprenorphine withdrawal symtoms [ Time Frame: Day -2 through Day 38 ] [ Designated as safety issue: No ]
    Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.
Same as current
Not Provided
Not Provided
 
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C
  • Opioid-Related Disorders
  • 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 Name: Suboxone
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
Interventions:
  • Drug: telaprevir
  • Drug: buprenorphine/naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Not Provided
April 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01275599
VX10-950-024
No
Scott McCallister, M.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Tibotec BVBA
Study Director: Scott McCallister, M.D. Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP