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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00671814

Acronym

SAD/MAD

Enrollment

Registered

2008-05-05

Start date

2008-01-06

Completion date

2008-06-06

Last updated

2017-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

antibiotic

Brief 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

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.

Interventions

DRUGTR-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.

DRUGlinezolid

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

DRUGplacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Adverse Event reporting	21 days

Secondary

Measure	Time frame
The PK rate and extent of urinary excretion of TR-701 and its microbiologically active moiety, TR-700	21 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026