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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Methadone

Drug: Lersivirine + Methadone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01099748

A5271031

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.