Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: fosamprenavir + ritonavir + methadone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Baltimore, Maryland 21287-5554, United States
GSK Investigational Site, Buffalo, New York 14215-1199, United States
Additional Information
Starting date: February 2005
Last updated: February 19, 2009
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