Trial | NCT00671814  Report issue

Title

Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults
A Double-Blind, Placebo and Active Controlled, Single and Multiple Rising Dose, Safety, Tolerance, and Pharmacokinetic Study of TR-701 in Normal Healthy Adults

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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
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.
Study Started
Jan 06
2008
Primary Completion
Jun 06
2008
Study Completion
Jun 06
2008
Last Update
Aug 31
2017

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.

Drug linezolid

Linezolid will be given at 600 mg twice daily for 21 days in cohort 10.

Drug 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.

1 Experimental

Single oral dose of TR-701 given once at 200mg, 400mg, 600mg, 800mg, and 1200mg. Multiple oral doses of TR-701 given once daily for 21 days at 200mg, 300mg and 400mg.

2 Placebo Comparator

Single oral dose of placebo given in cohorts 1-5. Multiple oral doses of placebo given once daily for 21 days in cohorts 6-8 and twice daily for 21 days in cohort 10.

3 Active Comparator

Oral doses of 600mg linezolid given twice daily for 21 days.

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
No Results Posted