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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TR-701 FA with Tyramine

TR-701 FA 200 oral with Tyramine

Group Type EXPERIMENTAL

TR-701 FA with Tyramine

Intervention Type DRUG

TR-701 FA 200 mg oral and Tyramine

Placebo-controlled with Tyramine

Group Type PLACEBO_COMPARATOR

Placebo-controlled withTyramine

Intervention Type DRUG

Placebo-controlled and Tyramine

Interventions

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TR-701 FA with Tyramine

TR-701 FA 200 mg oral and Tyramine

Intervention Type DRUG

Placebo-controlled withTyramine

Placebo-controlled and Tyramine

Intervention Type DRUG

Other Intervention Names

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Tedizolid Phosphate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes