A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Blinded, Placebo-Controlled, Crossover TR-701 FA Study of Blood Pressure Response Post-Tyramine Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539473
• Other study ID #: 1986-032
• Secondary ID: TR701-105
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2012
• Last updated: May 2, 2016
• Start date: February 2012
• Est. completion date: May 2012

Study information

• Verified date: May 2016
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase 1 study to determine the effect of oral TR-701 FA on SBP response when administered with tyramine

Description:

This is a Phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to determine the effect of 200 mg oral TR-701 FA on SBP response when administered with tyramine in healthy adult male and female volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male or female subjects between 18 to 45 years of age, inclusive

• Body mass index between 19 kg/m2 and 31 kg/m2, inclusive

• Healthy subjects with no clinically significant abnormalities identified by a detailed medical history,

Exclusion Criteria:

• Systolic blood pressure >130 mmHg or <90 mmHg measured after 10 minutes in the supine position at Screening or at admission to the study center

• Heart rate >90 bpm or <45 bpm measured after 10 minutes in the supine position

• Electrocardiogram (ECG) finding of QTc interval >500 msec, or other clinically significant ECG abnormality at the Screening Visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TR-701 FA with Tyramine
TR-701 FA 200 mg oral and Tyramine
• Placebo-controlled withTyramine
Placebo-controlled and Tyramine

Locations

Country	Name	City	State
United States	Trius Investigator Site 001	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Trius Therapeutics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure	14 days	No