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

A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: TR-701 FA with PSE; Other: TR-701 FA Placebo with PSE

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Trius Investigator Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TR-701 FA with PSE; TR-701 FA 200 mg oral with PSE	Drug: TR-701 FA with PSE; TR-701 FA Oral 200 mg oral with PSE; Other Names: Tedizolid Phosphate
Placebo Comparator: TR-701 FA Placebo with PSE; TR-701 FA Placebo 200 mg oral with PSE	Other: TR-701 FA Placebo with PSE; TR-701 FA Placebo Oral 200 mg with PSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo	13 days

Collaborators and Investigators

• Sponsor: Trius Therapeutics LLC
• Investigators: Study Chair: Philippe G Prokocimer, MD, Trius Therapeutics

Publications and helpful links

General Publications

• Flanagan S, Bartizal K, Minassian SL, Fang E, Prokocimer P. In vitro, in vivo, and clinical studies of tedizolid to assess the potential for peripheral or central monoamine oxidase interactions. Antimicrob Agents Chemother. 2013 Jul;57(7):3060-6. doi: 10.1128/AAC.00431-13. Epub 2013 Apr 22.
• Flanagan S, Minassian SL, Prokocimer P. Pharmacokinetics of Tedizolid and Pseudoephedrine Administered Alone or in Combination in Healthy Volunteers. J Clin Med. 2018 Jun 14;7(6):150. doi: 10.3390/jcm7060150.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2012
• Primary Completion (Actual): June 15, 2012
• Study Completion (Actual): June 15, 2012

Study Registration Dates

• First Submitted: April 11, 2012
• First Submitted That Met QC Criteria: April 12, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 19, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Tedizolid; Tedizolid phosphate
• Other Study ID Numbers: 1986-033; TR701-114 (Other Identifier: TriusRX Unique ID)