Drug-Drug Interaction Study Between Telaprevir and Buprenorphine

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275599
• Other study ID #: VX10-950-024
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2011
• Last updated: June 7, 2011
• Start date: January 2011

Study information

• Verified date: June 2011
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Tibotec BVBA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Blood levels of naloxone	Measured by maximum observed concentration (Cmax)	Day -1 and Day 7	No
Primary	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	No
Secondary	Safety and tolerability	Measured by incidence of treatment-emergent adverse events, clinical laboratory assessments, electrocardiogram outcomes, and vital signs.	Day -14 through Day 38	Yes
Secondary	Buprenorphine withdrawal symtoms	Measured by Clinical Opiate Withdrawal Scale (COWS), Desires for Drug Questionnaire (DDQ), and pupillometry.	Day -2 through Day 38	No