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
1 other identifier
interventional
16
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 11, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedJune 8, 2011
June 1, 2011
3 months
January 11, 2011
June 7, 2011
Conditions
Outcome Measures
Primary Outcomes (4)
Blood levels of buprenorphine
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.
Day -4 through Day 38
Blood levels of norbuprenorphine
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.
Day -4 through Day 38
Blood levels of naloxone
Measured by maximum observed concentration (Cmax)
Day -1 and Day 7
Blood levels of telaprevir
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.
Day 1 through Day 7
Secondary Outcomes (2)
Safety and tolerability
Day -14 through Day 38
Buprenorphine withdrawal symtoms
Day -2 through Day 38
Study Arms (1)
Open-Label Arm
EXPERIMENTALThe treatment period will include 3 phases: * 14 day run-in period * 7 day co-administration period * 31 day follow-up period
Interventions
Two 375 mg tablets administered every 8 hours on Day 1 through Day 7, inclusive.
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.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vertex Pharmaceuticals Incorporatedlead
- Tibotec BVBAcollaborator
Study Sites (2)
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott McCallister, M.D.
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 11, 2011
First Posted
January 12, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Last Updated
June 8, 2011
Record last verified: 2011-06