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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01539473

Run by

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

30

Starts

2012-02-01

Expected to finish

2012-05-01

Last updated by the study team

2016-05-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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

Where it is running

• Trius Investigator Site 001 — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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