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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577459
• Other study ID #: 1986-033
• Secondary ID: TR701-114
• Status: Completed
• Phase: Phase 1
• Start date: April 23, 2012
• Est. completion date: June 15, 2012

Study information

• Verified date: August 2018
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 15, 2012
• Est. primary completion date: June 15, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TR-701 FA with PSE
TR-701 FA Oral 200 mg oral with PSE

Other:
• TR-701 FA Placebo with PSE
TR-701 FA Placebo Oral 200 mg with PSE

Locations

Country	Name	City	State
United States	Trius Investigator Site 001	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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). pii: E150. doi: 10.3390/jcm7060150. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo	13 days