A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA
Overview
- Phase
- Phase 1
- Intervention
- TR-701 FA with PSE
- Conditions
- Healthy Subjects
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Systolic Blood Pressure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
TR-701 FA with PSE
TR-701 FA 200 mg oral with PSE
Intervention: TR-701 FA with PSE
TR-701 FA Placebo with PSE
TR-701 FA Placebo 200 mg oral with PSE
Intervention: TR-701 FA Placebo with PSE
Outcomes
Primary Outcomes
Systolic Blood Pressure
Time Frame: 13 days
To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo