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

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-23

Study Completion Date

2012-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TR-701 FA with PSE

TR-701 FA 200 mg oral with PSE

Group Type EXPERIMENTAL

TR-701 FA with PSE

Intervention Type DRUG

TR-701 FA Oral 200 mg oral with PSE

TR-701 FA Placebo with PSE

TR-701 FA Placebo 200 mg oral with PSE

Group Type PLACEBO_COMPARATOR

TR-701 FA Placebo with PSE

Intervention Type OTHER

TR-701 FA Placebo Oral 200 mg with PSE

Interventions

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TR-701 FA with PSE

TR-701 FA Oral 200 mg oral with PSE

Intervention Type DRUG

TR-701 FA Placebo with PSE

TR-701 FA Placebo Oral 200 mg with PSE

Intervention Type OTHER

Other Intervention Names

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Tedizolid Phosphate

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes