Healthy Volunteers
Conditions
Brief summary
Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine
Detailed 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.
Interventions
DRUGTR-701 FA with Tyramine
TR-701 FA 200 mg oral and Tyramine
DRUGPlacebo-controlled withTyramine
Placebo-controlled and Tyramine
Sponsors
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 14 days | To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure |
Countries
United States
Outcome results
None listed