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
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2008
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2008
CompletedFirst Submitted
Initial submission to the registry
May 1, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2008
CompletedApril 4, 2018
April 1, 2018
2 months
May 1, 2008
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the safety and tolerability of TR-701 600mg given as a single oral dose.
4 days
Secondary Outcomes (1)
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
Study Arms (2)
after fast
EXPERIMENTALAdministration of a single oral dose of 600mg TR-701 to subjects in the fasted state.
After high fat food
EXPERIMENTALAdministration of a single oral dose of 600mg TR-701 to subjects in the fed state.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance CRU
San Diego, California, 92123, United States
Related Publications (1)
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.
PMID: 23926058DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Berry, MD
Covance CRU
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2008
First Posted
May 5, 2008
Study Start
March 10, 2008
Primary Completion
May 15, 2008
Study Completion
May 15, 2008
Last Updated
April 4, 2018
Record last verified: 2018-04