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

NCT01099748 | Completed Phase 1

• 1 other identifier: A5271031
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Drug interaction; pharmacokinetics; lersivirine; methadone

Outcome Measures

Primary Outcomes (1)

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

  Day 12

Secondary Outcomes (2)

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

  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.

  Day 12

Study Arms (2)

Methadone

ACTIVE COMPARATOR

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

Drug: Methadone

Lersivirine + Methadone

EXPERIMENTAL

Drug: Lersivirine + Methadone

Interventions

Methadone DRUG

Methadone 50 - 150 mg QD (Day 1)

Methadone

Lersivirine + Methadone DRUG

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

Lersivirine + Methadone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• lead ECG demonstrating QTc \>450 msec for males and QTc \>470 msec for females or any other clinically significant abnormalities at screening.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Related Links

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

MeSH Terms

Interventions

Methadone; UK 453,061

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 7, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 30, 2010

Record last verified: 2010-08

Locations

US (1)