A Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects
This study has been completed.
Information provided by:
First received: April 8, 2011
Last updated: July 11, 2011
Last verified: July 2011
The purpose of this study is to:
- Compare the amount of study drug that is in the blood after taking either the capsule form of the drug or the tablet form of the drug while fasting.
- Determine the amount of study drug that is in the blood after eating a meal.
- Evaluate the safety of the tablet form of IDX184 in healthy people.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Official Title:||A Phase I, Open-label Study to Evaluate the Relative Bioavailability of IDX184 and Food Effect in Healthy Male Subjects|
Resource links provided by NLM:
Further study details as provided by Idenix Pharmaceuticals:
Primary Outcome Measures:
- Relative bioavailability [ Time Frame: 14 days ] [ Designated as safety issue: No ]Pharmacokinetic parameters, including area under the concentration-time curve (AUC) and maximum observed concentration (Cmax) of IDX184 and 2'-MeG, following oral administration of the capsule and tablet forms of IDX184.
- Blood levels of study drug measured in each study participant. [ Time Frame: 6 Days ] [ Designated as safety issue: No ]Pharmacokinetic parameters, including AUC and Cmax of IDX184 and 2'-MeG, following oral administration of a tablet form of IDX184 with and without food.
Secondary Outcome Measures:
- Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events [ Time Frame: 20 Days ] [ Designated as safety issue: No ]Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms.
|Study Start Date:||April 2011|
|Study Completion Date:||June 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Group A||
|Active Comparator: Group B||
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