Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate

NCT00876655 | Completed Phase 1

• 2 other identifiers: 1986-025TR701-108
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects

  4 days

Secondary Outcomes (1)

• To determine the safety and tolerability of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult

  4 days

Study Arms (2)

free acid

EXPERIMENTAL

TR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)

Drug: TR-701 free acid phosphate

di-sodium phosphate salt

EXPERIMENTAL

One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Drug: TR-701 di-sodium phosphate salt

Interventions

TR-701 di-sodium phosphate salt DRUG

One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

di-sodium phosphate salt

TR-701 free acid phosphate DRUG

One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)

free acid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs;
• Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or agree to use an acceptable form of contraception
• BMI of 18.5 to 32.0 kg/m2, inclusive

You may not qualify if:

• Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
• Pregnancy, lactation, or breastfeeding

Sponsors & Collaborators

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

Study Sites (1)

Covance Clinical Research Unit

Austin, Texas, 78752, United States

Location

Related Publications (1)

• Flanagan SD, Bien PA, Munoz KA, Minassian SL, Prokocimer PG. Pharmacokinetics of tedizolid following oral administration: single and multiple dose, effect of food, and comparison of two solid forms of the prodrug. Pharmacotherapy. 2014 Mar;34(3):240-50. doi: 10.1002/phar.1337. Epub 2013 Aug 7.

  PMID: 23926058 DERIVED

Study Officials

• David C Carter, MD

  Covance CRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 7, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

US (1)