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

Sponsor

Trius Therapeutics LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00671359

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TR-701 600mg	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

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 :

Mar 10, 2008

Actual Primary Completion Date :

May 15, 2008

Actual Study Completion Date :

May 15, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: after fast Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.	Drug: TR-701 600mg 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 TR-701 600mg

Arm

Intervention/Treatment

Experimental: after fast

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

Drug: TR-701 600mg

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

TR-701 600mg

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance CRU	San Diego	California	United States	92123

Sponsors and Collaborators

Trius Therapeutics LLC

Investigators

Principal Investigator: Michael Berry, MD, Covance CRU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Trius Therapeutics LLC

ClinicalTrials.gov Identifier:

NCT00671359

Other Study ID Numbers:

1986-023
TR701-103

First Posted:

May 5, 2008

Last Update Posted:

Apr 4, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Trius Therapeutics LLC

Food effects

Additional relevant MeSH terms:

Tedizolid phosphate

Study Results

No Results Posted as of Apr 4, 2018