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)

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Other: TR-701 FA Placebo with PSE

Drug: TR-701 FA with PSE

Study type

Interventional

Funder types

Industry

Identifiers

NCT01577459

1986-033

TR701-114 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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