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

Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)18 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Subjects

Interventions

TR-701 FA with PSEDRUG

TR-701 FA Oral 200 mg oral with PSE

TR-701 FA Placebo with PSEOTHER

TR-701 FA Placebo Oral 200 mg with PSE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Trius Investigator Site 001

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Systolic Blood Pressure

To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo

Time frame: 13 days

Data from ClinicalTrials.gov

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