Back to resultsDrug-Drug Interaction Study Between Telaprevir and Buprenorphine
Primary Purpose
Hepatitis C, Opioid-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
telaprevir
buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-Label Arm
Arm Description
The treatment period will include 3 phases: 14 day run-in period 7 day co-administration period 31 day follow-up period
Outcomes
Primary Outcome Measures
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.
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.
Blood levels of naloxone
Measured by maximum observed concentration (Cmax)
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.
Secondary Outcome Measures
Safety and tolerability
Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs.
Buprenorphine withdrawal symtoms
Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.
Full Information
NCT ID
NCT01275599
First Posted
January 11, 2011
Last Updated
June 7, 2011
Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec BVBA
1. Study Identification
Unique Protocol Identification Number
NCT01275599
Brief Title
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec BVBA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open-Label Arm
Arm Type
Experimental
Arm Description
The treatment period will include 3 phases:
14 day run-in period
7 day co-administration period
31 day follow-up period
Intervention Type
Drug
Intervention Name(s)
telaprevir
Intervention Description
Two 375 mg tablets administered every 8 hours on Day 1 through Day 7, inclusive.
Intervention Type
Drug
Intervention Name(s)
buprenorphine/naloxone
Other Intervention Name(s)
Suboxone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood levels of buprenorphine
Description
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.
Time Frame
Day -4 through Day 38
Title
Blood levels of norbuprenorphine
Description
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.
Time Frame
Day -4 through Day 38
Title
Blood levels of naloxone
Description
Measured by maximum observed concentration (Cmax)
Time Frame
Day -1 and Day 7
Title
Blood levels of telaprevir
Description
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.
Time Frame
Day 1 through Day 7
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs.
Time Frame
Day -14 through Day 38
Title
Buprenorphine withdrawal symtoms
Description
Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.
Time Frame
Day -2 through Day 38
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott McCallister, M.D.
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
Overland Park
State/Province
Kansas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
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