Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
|First Submitted Date ICMJE||May 30, 2007|
|First Posted Date ICMJE||June 1, 2007|
|Last Update Posted Date||February 23, 2009|
|Start Date ICMJE||February 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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).|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00481182 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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.|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.|
|Official Title ICMJE||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|
|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.|
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Healthy Subjects|
|Intervention ICMJE||Drug: fosamprenavir + ritonavir + methadone|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Ages||18 Years to 64 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00481182|
|Other Study ID Numbers ICMJE||102577|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Study Director, GSK|
|Study Sponsor ICMJE||GlaxoSmithKline|
|Collaborators ICMJE||Not Provided|
|Verification Date||February 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP