A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.

Key facts

Study ID

NCT01577459

Run by

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

People needed

18

Starts

2012-04-23

Expected to finish

2012-06-15

Last updated by the study team

2018-08-21

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 and 45 years of age, inclusive
• Healthy males and females with no clinically significant abnormalities identified by a detailed medical history
• Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2

You may not qualify if…

• Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
• Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1
• Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day
• Known allergy or hypersensitivity to PSE

Where it is running

• Trius Investigator Site 001 — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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