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Completed

NCT Number: NCT01275599

Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Telaprevir

Drug

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

buprenorphine/naloxone

Drug

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

Primary outcomes

  1. Blood levels of buprenorphine

    Time frame: 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

    Time frame: 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

    Time frame: Day -1 and Day 7

    Measured by maximum observed concentration (Cmax)

  4. Blood levels of telaprevir

    Time frame: 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 outcomes

  1. Safety and tolerability

    Time frame: 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

    Time frame: Day -2 through Day 38

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

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Collaborators

  • Tibotec BVBA

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
First posted
Jan 12, 2011
Registry last updated
Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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