Single and Multiple Ascending Dose Pharmacokinetic Study of TR701 in Healthy Adults (SAD/MAD)

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: linezolid; Drug: TR-701; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00671814

TR701-101 (Other Identifier)

1986-016

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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80 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Drug: TR-701

2

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo

3

Active Comparator group

Description:

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

Treatment:

Drug: linezolid