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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
  Purpose

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 Intervention Phase
Hepatitis C
Opioid-Related Disorders
 Drug: telaprevir
Drug: buprenorphine/naloxone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 16
Study Start Date: January 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Suboxone

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275599

Locations
United States, Kansas
Overland Park, Kansas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Tibotec BVBA
Investigators
Study Director: Scott McCallister, M.D. Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Scott McCallister, M.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01275599     History of Changes
Other Study ID Numbers: VX10-950-024
Study First Received: January 11, 2011
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Opioid-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Substance-Related Disorders
Mental Disorders
 Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013