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

Condition(s) targeted: Healthy Volunteers

Intervention: Methadone (Drug); Lersivirine + Methadone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: Open Label, Single-Sequence Study To Estimate The Effect Of Lersivirine (UK-453,061) On S- And R-Methadone In Subjects Receiving Chronic Methadone Treatment

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

Primary outcome: R-methadone and S-methadone plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h on Days 1 and 11

Secondary outcome:

Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments

Symptoms of methadone withdrawal as assessed by the Short Opiate Withdrawal Scale (SOWS), Desires for Drug Questionnaire (DDQ) and Pupillary Diameter measurement performed on Days 0 -12.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Philadelphia, Pennsylvania 19139, United States

To obtain contact information for a study center near you, click here.

Starting date: May 2010
Last updated: August 26, 2010