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)30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

TR-701 FA with TyramineDRUG

TR-701 FA 200 mg oral and Tyramine

Placebo-controlled withTyramineDRUG

Placebo-controlled and Tyramine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Trius Investigator Site 001

Evansville, Indiana, United States

Outcomes

Primary Outcomes

Systolic Blood Pressure

To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure

Time frame: 14 days

Data from ClinicalTrials.gov

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