NCT00481182

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
Last Updated

February 23, 2009

Status Verified

February 1, 2009

First QC Date

May 30, 2007

Last Update Submit

February 19, 2009

Conditions

Healthy Subjects

Keywords

PKPDFPVRTVAPVritonavirfosamprenaviramprenavirmethadonepharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Interventions

fosamprenavir + ritonavir + methadoneDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Baltimore, Maryland, 21287-5554, United States

Location

GSK Investigational Site

Buffalo, New York, 14215-1199, United States

Location

MeSH Terms

Interventions

fosamprenavirRitonavirMethadone

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsKetones

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2007

First Posted

June 1, 2007

Study Start

February 1, 2005

Last Updated

February 23, 2009

Record last verified: 2009-02

Locations

US(2)