Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
Completed · Phase 1
Conditions studied: Hepatitis C, Opioid-Related Disorders
In brief
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.
Key facts
- Study ID
- NCT01275599
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 16
- Starts
- 2011-01-01
- Last updated by the study team
- 2011-06-08
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Study site — Overland Park, Kansas, United States
- Study site — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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