A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/4/2016 |
| Start Date: | February 2012 |
| End Date: | May 2012 |
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
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.
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
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