- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00671359
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Covance CRU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: after fast
Administration of a single oral dose of 600mg TR-701 to subjects in the fasted state.
|
TR-701 600mg
|
Experimental: After high fat food
Administration of a single oral dose of 600mg TR-701 to subjects in the fed state.
|
TR-701 600mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the safety and tolerability of TR-701 600mg given as a single oral dose.
Time Frame: 4 days
|
4 days
|
Secondary Outcome Measures
Outcome 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
Time Frame: 4 days
|
4 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Berry, MD, Covance CRU
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1986-023
- TR701-103 (Other Identifier: TriusRX Unique ID)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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