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

A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge

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.

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