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

• Status: Completed
• Trial end date: 2012-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Trius Therapeutics LLC
• Treatments: Tedizolid; Tedizolid phosphate; Torezolid phosphate

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