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

NCT ID: NCT00671359

Last Updated: 2018-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-10
• Study Completion Date: 2008-05-15

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

after fast

Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.

Group Type: EXPERIMENTAL

TR-701 600mg

Intervention Type: DRUG

TR-701 600mg

After high fat food

Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.

Group Type: EXPERIMENTAL

TR-701 600mg

Intervention Type: DRUG

TR-701 600mg

Interventions

TR-701 600mg

TR-701 600mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Berry, MD

Role: PRINCIPAL_INVESTIGATOR

Covance CRU

Locations

Covance CRU

San Diego, California, United States

Countries

United States

References

Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

Reference Type: DERIVED

PMID: 23926058 (View on PubMed)

Other Identifiers

TR701-103

Identifier Type: OTHER

Identifier Source: secondary_id

1986-023

Identifier Type: -

Identifier Source: org_study_id