A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge
Sponsored by Trius Therapeutics LLC
About this trial
Last updated 9 years ago
Study ID
1986-032
Status
Completed
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18 to 45 Years
All
Trial Timing
Ended 13 years ago
What is this trial about?
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered
with tyramine
What are the participation requirements?
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