Food Effects of Single Oral Dose of 600mg TR-701

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TR-701 600mg

• Registration Number: NCT00671359
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Timeline

• Study Start: 2008-03-10
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Primary Completion: 2008-05-15
• Study Completion: 2008-05-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• BMI of 20 to 29.9 kg/m2
• Females must be either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable method of birth control

Exclusion Criteria

• history or clinical manifestations of any clinically significant medical disorder
• history of hypersensitivity or allergies to any drug compound
• history of stomach or intestinal surgery or resection
• history of alcoholism or drug addiction within 1 year
• pregnancy, lactation, or breastfeeding
• use of any tobacco-containing or nicotine-containing products within 6 months
• use of any other medications
• use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages; or foods or beverages with high levels of tyramine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
after fast	TR-701 600mg	Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.
After high fat food	TR-701 600mg	Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of TR-701 600mg given as a single oral dose.	4 days

Secondary Outcome Measures

Name	Time	Method
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	4 days

Trial Locations

Locations (1)

Covance CRU; 🇺🇸 San Diego, California, United States