Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT00671359
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2008-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effects of Single Oral Dose of 600mg TR-701
Sponsor:
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TR701-103 | OTHER | TriusRX Unique ID | View |