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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-06

Study Completion Date

2008-06-06

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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.

Group Type EXPERIMENTAL

TR-701

Intervention Type DRUG

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.

2

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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.

3

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

Group Type ACTIVE_COMPARATOR

linezolid

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

linezolid

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes