Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00481182
First received: May 30, 2007
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID + standardized dose of methadone, on plasma total and unbound methadone enantiomer pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of methadone on plasma amprenavir PK will also be assessed by comparison to historical control data.


Condition Intervention Phase
Healthy Subjects
Drug: fosamprenavir + ritonavir + methadone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, 2-Period, Single-Sequence, Drug Interaction Study to Assess Steady-State Plasma Methadone Enantiomer Pharmacokinetics Following Co-Administration of Methadone QD With Fosamprenavir 700mg BID + RTV 100mg BID in Opiate-Dependent, HIV Seronegative, Adult Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serial blood samples will be collected over 24 hours for measurement of plasma (R-) and (S-) methadone (days 4 and 18) and serum amprenavir concentrations (day 18).

Secondary Outcome Measures:
  • On study days 4, 11, and 18, opioid effects will be assessed pre-dose, 2 hours, and 6 hours following methadone dosing. Pharmacokinetic and opioid pharmacodynamic parameters will be compared between the two treatments.

Estimated Enrollment: 20
Study Start Date: February 2005
Intervention Details:
    Drug: fosamprenavir + ritonavir + methadone
    Other Name: fosamprenavir + ritonavir + methadone
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is enrolled in a certified methadone maintenance program for at least 12 weeks prior to Period 1, Day 1.

Subject is receiving methadone = 200mg QD that has remained unchanged for 30 days The subject is male, female and is between the age of 18 and 64 years of age.

A female is eligible to enter and participate if she is of non-childbearing potential or of childbearing potential. If of childbearing potential, females must have a negative serum pregnancy test at Screening, and agree to one of the following:

Complete abstinence from sexual intercourse from 2 weeks prior to administration of the study drug. Sexual intercourse with only vasectomized partner.

Body mass index of 19.00 to 32.00 kg/m2. Willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.

Able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.

Able to give written informed consent prior to screening.

Exclusion Criteria:

  • Subject has a clinically significant abnormality identified on the screening medical or laboratory evaluation, including 12-lead ECG.

Subject has any preexisting condition which could interfere with the absorption, metabolism, and/or excretion of the study drugs.

Subject currently has or has a history of decompensated liver disease (i.e., ascites, esophageal or rectal varices, hepatic encephalopathy) or current evidence of active hepatitis (AST or ALT > 2.5x ULN).

Subject has evidence of liver impairment at screening (i.e., INR > 1.7, total bilirubin >2.0 mg/dL, albumin <3.5 g/dL).

Subject has inadequate venous access. Subject has a history of any hypersensitivity reaction to any component of FPV, APV, RTV, or to any drug chemically related to FPV, APV, or RTV.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481182

Locations
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21287-5554
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14215-1199
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00481182     History of Changes
Other Study ID Numbers: 102577
Study First Received: May 30, 2007
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
PK
PD
FPV
RTV
APV
ritonavir
fosamprenavir
amprenavir
methadone
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Methadone
Ritonavir
Fosamprenavir
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 14, 2014