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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: TR-701 FA with PSE; Other: TR-701 FA Placebo with PSE

• Registration Number: NCT01577459
• Lead Sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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.

Study Timeline

• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Study Start: 2012-04-23
• Primary Completion: 2012-06-15
• Study Completion: 2012-06-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-19
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TR-701 FA with PSE	TR-701 FA with PSE	TR-701 FA 200 mg oral with PSE
TR-701 FA Placebo with PSE	TR-701 FA Placebo with PSE	TR-701 FA Placebo 200 mg oral with PSE

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	13 days	To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo

Trial Locations

Locations (1)

Trius Investigator Site 001; 🇺🇸 Overland Park, Kansas, United States