Food Effects of Single Oral Dose of 600mg TR-701
This is an evaluation of the safety, tolerance, and pharmacokinetics of single oral doses of TR-701 given to normal, healthy, adult volunteers in the fed and fasted state.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open-Label, Single-Dose, Two-Treatment, Randomized, Two-Way Crossover, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults in the Fed and Fasted State|
- To determine the safety and tolerability of TR-701 600mg given as a single oral dose. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
- To evaluate the pharmacokinetics of single doses of TR-701 and its microbiologically active moiety, TR-700, in healthy adult volunteers in the fed and fasted state [ Time Frame: 4 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Experimental: after fast
Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.
Drug: TR-701 600mg
Experimental: After high fat food
Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.
Drug: TR-701 600mg
Subjects will receive the following treatments in a crossover design:
Treatment A: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water after at least a 10-hour fast.
Treatment B: Three 200-mg capsules (600-mg dose) of TR-701 administered orally with 240 mL room temperature tap water following a high-fat meal preceded by at least a 10-hour fast.
Descriptive statistics will be calculated for PK parameters where available, including Cmax, Tmax, AUC0-t, and AUC0-inf. Minimum, maximum, mean, and median values will be determined and standard deviations will be calculated. Where data are available, food effect will be examined between test (fed state) and reference (fasted state) groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671359
|United States, California|
|San Diego, California, United States, 92123|
|Principal Investigator:||Michael Berry, MD||Covance CRU|