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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442831
• Other study ID #: 1986-024
• Secondary ID: TR701-106
• Status: Completed
• Phase: Phase 1
• Start date: September 9, 2010
• Est. completion date: September 22, 2010

Study information

• Verified date: November 2019
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 22, 2010
• Est. primary completion date: September 22, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Human ADME
Oral single dose

Locations

Country	Name	City	State
United States	Trius Investigator Site 001	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ong V, Flanagan S, Fang E, Dreskin HJ, Locke JB, Bartizal K, Prokocimer P. Absorption, distribution, metabolism, and excretion of the novel antibacterial prodrug tedizolid phosphate. Drug Metab Dispos. 2014 Aug;42(8):1275-84. doi: 10.1124/dmd.113.056697. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the single dose plasma PK of TR-700, the microbiologically active molecule	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	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