Microdialysis and Pharmacokinetic Study of TR-701

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TR-701 (pro-drug); Drug: TR-700 (active moiety)

• Registration Number: NCT00666601
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief Summary

The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose tissue and skeletal muscle after a single oral dose of 600 mg TR-701

Detailed Description

This study will be conducted in two parts: a Pilot Study and a Main Study. The Pilot Study will be conducted to assess recovery of exogenously administered TR-700 (microbiologically active moiety) via microdialysis. In the Main Study, pharmacokinetics of TR-700 will be determined in both soft tissues (via microdialysis) and plasma after a single oral dose of 600 mg TR-701 (prodrug).

Study Timeline

• Study Start: 2008-04-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Primary Completion: 2008-08-12
• Study Completion: 2008-08-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Body mass index of 20 to 29 kg/m2
• Agree not to consume any products containing tobacco, alcohol, quinine, grapefruit, caffeine, or high levels of tyramine
• Agree not to use any other medication
• Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control

Exclusion Criteria

• History of gastric or duodenal ulcer within 1 year before enrollment
• Has known or suspected hypersensitivity or intolerance to heparin, if an indwelling cannula (e.g., heparin lock) is used
• Recent febrile illness (less than 72 hours before the first intake of study medication).
• Significant blood loss (300 mL) or donation of blood within the 60 days before the Screening visit
• Women who are pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main Study	TR-701 (pro-drug)	12 subjects, open label, single dose of 600 mg.
Pilot study	TR-700 (active moiety)	3 subjects, open lable, microdialysis single dose.

Primary Outcome Measures

Name	Time	Method
Subcutaneous tissue concentrations of TR-700	Single day

Trial Locations

Locations (1)

General Clinical Research Center; 🇺🇸 Gainesville, Florida, United States