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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00481182 |
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 |
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Healthy Subjects |
Drug: fosamprenavir + ritonavir + methadone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | February 2005 |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 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.
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 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 102577 |
Study First Received: | May 30, 2007 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00481182 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
PK PD FPV RTV APV ritonavir |
fosamprenavir amprenavir methadone pharmacokinetics pharmacodynamics |
HIV Protease Inhibitors Anti-HIV Agents Acquired Immunodeficiency Syndrome Central Nervous System Depressants Narcotics Healthy Antiviral Agents Protease Inhibitors Naphazoline Methadone |
Amprenavir Anti-Retroviral Agents Fosamprenavir HIV Infections Ritonavir Guaifenesin Peripheral Nervous System Agents Phenylpropanolamine Analgesics Analgesics, Opioid |
Anti-Infective Agents Respiratory System Agents HIV Protease Inhibitors Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Depressants Enzyme Inhibitors Narcotics Antiviral Agents Pharmacologic Actions Protease Inhibitors |
Methadone Anti-Retroviral Agents Fosamprenavir Ritonavir Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Antitussive Agents Central Nervous System Agents Analgesics, Opioid |