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fosamprenavir + ritonavir + methadone

Phase 1

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Feb 23, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00481182Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.PHASE1 COMPLETED 20 — — Feb 1, 2005 -Feb 23, 20092 United States
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Study Endpoints
Primary Endpoints
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 Endpoints
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.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
fosamprenavir + ritonavir + methadoneDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 ...

Countries:United States
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