Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-06-30

Brief Summary

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The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methadone

Dose of methadone must not change from 1 week prior to study start and through the duration of the study.

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

Methadone 50 - 150 mg QD (Day 1)

Lersivirine + Methadone

Group Type EXPERIMENTAL

Lersivirine + Methadone

Intervention Type DRUG

Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)

Interventions

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Methadone

Methadone 50 - 150 mg QD (Day 1)

Intervention Type DRUG

Lersivirine + Methadone

Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history except drug abuse), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Receiving stable methadone maintenance treatment for at least 3 months (dose range 50-150 mg QD).

Exclusion Criteria

* Subjects on therapy for Hepatitis B and/or Hepatitis C; Evidence of impaired liver function (ie, AST and/or ALT greater than 3 times the upper limit of normal, total bilirubin \>1.5 times the upper limit of normal, albumin \<3.5 g/dL).
* 12-lead ECG demonstrating QTc \>450 msec for males and QTc \>470 msec for females or any other clinically significant abnormalities at screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes