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

Sponsor

Trius Therapeutics LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00876655

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TR-701 di-sodium phosphate salt Drug: TR-701 free acid phosphate	Phase 1

Detailed Description

Subjects will receive the following treatments in a crossover design:

Treatment A (Reference): One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

Treatment B (Test): One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700) administered orally after at least an 8-hour fast with 240 mL room temperature water;

Descriptive statistics will be calculated for PK parameters including Cmax, Tmax, AUC0-t, and AUC0-inf.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

An Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Sequence, Crossover, Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of TR-701 (Torezolid Phosphate) in Normal Healthy Adults

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: free acid TR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)	Drug: TR-701 free acid phosphate One 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
Experimental: di-sodium phosphate salt One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)	Drug: TR-701 di-sodium phosphate salt One 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Arm

Intervention/Treatment

Experimental: free acid

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

Drug: TR-701 free acid phosphate

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

Experimental: di-sodium phosphate salt

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

Drug: TR-701 di-sodium phosphate salt

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research Unit	Austin	Texas	United States	78752

Sponsors and Collaborators

Trius Therapeutics LLC

Investigators

Principal Investigator: David C Carter, MD, Covance CRU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Trius Therapeutics LLC

ClinicalTrials.gov Identifier:

NCT00876655

Other Study ID Numbers:

1986-025
TR701-108

First Posted:

Apr 7, 2009

Last Update Posted:

May 3, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Tedizolid phosphate

Study Results

No Results Posted as of May 3, 2016