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

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Phoenix, Arizona, 85044 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00447629
Pfizer
Completed
Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Study Evaluating Single Doses of PPM-204 on the Electrical Pathways of the Heart
Official Title  ICMJE 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
Brief SummaryA study evaluating the safety of a high and low dose of PPM-204 on the electrical pathways of the heart.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE Drug: PPM-204
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447629
Other Study ID Numbers  ICMJE 3180A1-1109
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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