Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart

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

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-03-31

Brief Summary

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A study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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PPM-204

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women, aged 18 to 55 years
* Body mass index in the range of 18 to 30 kg/m2
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG

Exclusion Criteria

* History of cardiac, thyroid, muscle, or kidney abnormalities
* A family history of long QT syndrome and/or sudden cardiac death
* History of any clinically significant drug allergy, hypersensitivity to sulfonomides or the quinolone class of antibiotics

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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3180A1-1109

Identifier Type: -

Identifier Source: org_study_id