Microdialysis and Pharmacokinetic Study of TR-701

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

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: TR-700 (active moiety)

Drug: TR-701 (pro-drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00666601

TR701-102 (Other Identifier)

1986-022

Details and patient eligibility

About

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

Full 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).

Enrollment

15 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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