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

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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00671359

Enrollment

Registered

2008-05-05

Start date

2008-03-10

Completion date

2008-05-15

Last updated

2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Food effects

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.

Interventions

DRUGTR-701 600mg

TR-701 600mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026