A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge

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

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo-controlled withTyramine

Drug: TR-701 FA with Tyramine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01539473

1986-032

TR701-105 (Other Identifier)

Details and patient eligibility

About

Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

Full description

This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female subjects between 18 to 45 years of age, inclusive
Body mass index between 19 kg/m2 and 31 kg/m2, inclusive
Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,

Exclusion criteria

Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center
Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position
Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit