Food Effects of Single Oral Dose of 600mg TR-701
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|ClinicalTrials.gov Identifier: NCT00671359|
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: TR-701 600mg||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (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|
|Actual Study Start Date :||March 10, 2008|
|Actual Primary Completion Date :||May 15, 2008|
|Actual Study Completion Date :||May 15, 2008|
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
- To determine the safety and tolerability of TR-701 600mg given as a single oral dose. [ Time Frame: 4 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671359
|United States, California|
|San Diego, California, United States, 92123|
|Principal Investigator:||Michael Berry, MD||Covance CRU|