Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects

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

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Human ADME

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442831

1986-024

TR701-106 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to describe the single dose pharmacokinetics of total radioactivity in plasma and whole blood following PO administration of [14C] TR-701 in healthy adult male subjects.

Full description

This study will be an open-label, single-dose study of the absorption, metabolism, and excretion of 200 mg [14C]-TR-701 (approximately 100 μCi) administered orally following at least an 8-hour fast. Subjects will receive a single dose of 200 mg [14C] TR 701 (approximately 100 μCi) administered as an oral solution.

The dose will be administered following at least an 8-hour fast and followed by a 4-hour fast from food, not including water.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males, between 18 and 50 years of age, inclusive.
2. Body mass index (BMI) of 20 kg/m2 to 29.9 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs.

Exclusion criteria

1. Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator and Sponsor).
2. History of an abnormal ECG that is clinically significant in the opinion of the Investigator.
3. History of hypersensitivity, intolerance, or allergy to antibiotics of the oxazolidinone class, to any ingredient of the formulation.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Human ADME

Experimental group

Treatment:

Drug: Human ADME