Pulmonary Disposition of TR-700 Following Once-Daily Oral 200 mg

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

Status and phase: Completed; Phase 1

Conditions: Bacterial Infection

Treatments: Drug: TR-701 FA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01271998

1986-027

TR701-119 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to determine the steady-state plasma pharmacokinetics (PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) of healthy volunteers.

Full description

No applicable.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males and females, between 18 and 55 years of age, inclusive
• Females must be nonpregnant, nonlactating, and either postmenopausal or surgically sterile or practicing an effective method of birth control
• Males must be surgically sterile, abstinent, or practicing an effective method of birth control
• BMI between 20 and 34.9 kg/m2, inclusive

Exclusion criteria

• Allergy to lidocaine, midazolam, or other anesthetics/sedatives of similar classes
• Physician-diagnosed migraine headaches within 3 years
• Previous enrollment in a TR-701 or TR-701 FA trial

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

healthy volunteer

Experimental group

Description:

healthy volunteers

Treatment:

Drug: TR-701 FA