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

A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)- Controlled, 4-Period Crossover Study of the Effects of Single Oral Doses of PPM 204 on Cardiac Repolarization in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447629

Enrollment

Unknown

Registered

2007-03-15

Start date

2007-01-31

Completion date

2007-03-31

Last updated

2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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

Interventions

DRUGPPM-204

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Pharmacokinetics	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026