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

August 26, 2010 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19139
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methadone
Dose of methadone must not change from 1 week prior to study start and through the duration of the study.
Drug: Methadone
Methadone 50 - 150 mg QD (Day 1)
Experimental: Lersivirine + Methadone
Drug: Lersivirine + Methadone
Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
R-methadone and S-methadone plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h on Days 1 and 11
Time Frame: Day 12
Day 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
Time Frame: Day 12
Day 12
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.
Time Frame: Day 12
Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 6, 2010

First Posted (Estimate)

April 7, 2010

Study Record Updates

Last Update Posted (Estimate)

August 30, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5271031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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