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

NCT01442831 | Completed Phase 1

• 2 other identifiers: 1986-024TR701-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

metabolic profile of TR-700 in plasma urine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Human ADME

EXPERIMENTAL

Drug: Human ADME

Interventions

Human ADME DRUG

Oral single dose

Human ADME

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).
• History of an abnormal ECG that is clinically significant in the opinion of the Investigator.
• History of hypersensitivity, intolerance, or allergy to antibiotics of the oxazolidinone class, to any ingredient of the formulation.

Sponsors & Collaborators

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

Study Sites (1)

Trius Investigator Site 001

Madison, Wisconsin, 53704, United States

Location

Related 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. Epub 2014 May 29.

  PMID: 24875463 RESULT

Study Officials

• Philippe G Prokocimer, MD

  Trius Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: September 29, 2011
• Study Start: September 9, 2010
• Primary Completion: September 22, 2010
• Study Completion: September 22, 2010
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)