Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults
Information source: Trius Therapeutics LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects
Intervention: TR-701 (Drug); linezolid (Drug); placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Trius Therapeutics LLC Official(s) and/or principal investigator(s): John Bohn, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
single rising oral doses and multiple oral doses of TR-701
Clinical Details
Official title: A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Adverse Event reporting
Secondary outcome: The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700
Detailed description:
This is an evaluation of TR-701 in a double-blind, placebo-controlled, randomized, single
(Part A) and multiple (Part B) ascending dose safety, tolerance, and PK when administered as
a capsule in normal, healthy adult volunteers. The study will be sequential between Part A
and Part B (i. e., not staggered or leap frogged), with slight overlap between last cohort in
Part A and first cohort in Part B.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- in good health
- body mass index of 20 to 29. 9 kg/m2
- female subjects must be either postmenopausal for at least 1 year, surgically
sterile, abstinent, or agree to use an effective method of birth control
Exclusion Criteria:
- history or clinical manifestations of any clinically significant 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
- 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
- pregnancy, lactation, or breastfeeding
Locations and Contacts
Covance Clinical Research Unit, Madison, Wisconsin 53704, United States
Additional Information
Starting date: January 2008
Last updated: June 1, 2012
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