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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19139 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

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

NCT01099748
Pfizer
Completed
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone

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Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: Methadone
    Methadone 50 - 150 mg QD (Day 1)
  • Drug: Lersivirine + Methadone
    Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)
  • Active Comparator: Methadone
    Dose of methadone must not change from 1 week prior to study start and through the duration of the study.
    Intervention: Drug: Methadone
  • Experimental: Lersivirine + Methadone
    Intervention: Drug: Lersivirine + Methadone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01099748
A5271031
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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