- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481182
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287-5554
- GSK Investigational Site
-
-
New York
-
Buffalo, New York, United States, 14215-1199
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Protease Inhibitors
- Analgesics, Opioid
- Narcotics
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Respiratory System Agents
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitussive Agents
- Ritonavir
- Methadone
- Fosamprenavir
Other Study ID Numbers
- 102577
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Subjects
-
BiogenCompletedHealthy Adult Subjects | Healthy Elderly SubjectsUnited States
-
PfizerCompletedHealthy Adult Subjects and Healthy Elderly SubjectsBelgium
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHealthy | Healthy Subjects | ImmunosuppressionUnited States
-
Lund UniversityCompletedHealthy Subjects | Diet, HealthySweden
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Shouyao Holdings (Beijing) Co. LTDNot yet recruiting
-
Abbisko Therapeutics Co, LtdNot yet recruiting
-
Vigonvita Life SciencesRecruiting
Clinical Trials on fosamprenavir + ritonavir + methadone
-
GlaxoSmithKlineTerminatedHIV-1Australia, Belgium, Canada, France, Germany, Greece, Italy, Spain, United Kingdom
-
GlaxoSmithKlineCompletedHIV Infection | Infection, Human Immunodeficiency VirusUnited States, Puerto Rico
-
ViiV HealthcarePfizerTerminated
-
ViiV HealthcarePfizerCompleted
-
ViiV HealthcareGlaxoSmithKlineCompletedHIV-1 Infection | Infection, Human Immunodeficiency Virus IGermany, Spain, France, Belgium, United Kingdom, Italy, Romania, Russian Federation, Switzerland
-
ViiV HealthcareGlaxoSmithKlineCompletedInfection, Human Immunodeficiency VirusUnited States, Spain, France, United Kingdom, Chile, Brazil, Italy, Portugal
-
ViiV HealthcareCompletedHIV InfectionUnited States, Spain, Portugal, Italy, Romania, Canada, Netherlands
-
Emory UniversityCompletedHIV InfectionsUnited States
-
The University of Texas Health Science Center,...Completed
-
Tibotec BVBACompleted