Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults

Healthy Subjects Clinical Trial

— SAD/MAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671814
• Other study ID #: 1986-016
• Secondary ID: TR701-101
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2008
• Last updated: August 30, 2017
• Start date: January 6, 2008
• Est. completion date: June 6, 2008

Study information

• Verified date: August 2017
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 6, 2008
• Est. primary completion date: June 6, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TR-701
TR-701 will be given as single oral doses in Cohorts 1-5 and as once daily oral doses for 21 days in cohorts 6-8.
• linezolid
Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.
• placebo
Placebo will be given once for cohorts 1-5, once daily for 21 days for cohorts 6-8, and twice daily for 21 days for cohort 10.

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event reporting		21 days
Secondary	The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700		21 days