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

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-TR-701 in Healthy Adult Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01442831

Enrollment

Registered

2011-09-29

Start date

2010-09-09

Completion date

2010-09-22

Last updated

2019-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

metabolic profile of TR-700 in plasma urine

Brief summary

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.

Detailed 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.

Interventions

DRUGHuman ADME

Oral single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
To describe the single dose plasma PK of TR-700, the microbiologically active molecule	pre dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, then daily up to 312 hours post dose	To describe the single dose pharmacokinetics (Cmax, Tmax, AUC, t 1/2, CL/F) of total radioactivity in plasma, whole blood, urine and feces following oral (PO) administration of \[14C\] TR 701 in healthy adult male subjects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026