NCT01577459

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

A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TR-701 FA with PSE	TR-701 FA Oral 200 mg oral with PSE
OTHER	TR-701 FA Placebo with PSE	TR-701 FA Placebo Oral 200 mg with PSE

Timeline

• Start date: 2012-04-23
• Primary completion: 2012-06-15
• Completion: 2012-06-15
• First posted: 2012-04-13
• Last updated: 2018-08-21

Locations

1 site across 1 country: United States