CP-690,550 Thorough QTc Study

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NCT01743677

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Study Location
Pfizer Clinical Research Unit
Bruxelles, , 1070, Belgium
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Contact
1-800-718-1021
[email protected]
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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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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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

- Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.

- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

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


- Use of tobacco- or nicotine-containing products in excess of equivalent of 5
cigarettes per day.


- 12-lead ECG demonstrating QTc >450 msec or other clinically significant abnormalities
at Screening.


- History of risk factors for QT prolongation or torsades de pointes.


- Pregnant or nursing women; women of childbearing potential unwilling or unable to use
an acceptable method of nonhormonal contraception from at least 14 days prior to first
dose until completion of follow-up.


- Use of prescription or nonprescription drugs, vitamins and dietary supplements within
7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.


- Any clinically significant infections within past 3 months or evidence of infection in
past 7 days.

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
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Advanced Information
Descriptive Information
Brief Title  ICMJE CP-690,550 Thorough QTc Study
Official Title  ICMJE A PHASE 1, RANDOMIZED, PLACEBO- AND POSITIVE-CONTROLLED CROSS-OVER STUDY TO DETERMINE THE EFFECT OF SINGLE-DOSE CP-690,550 ON QTC INTERVAL IN HEALTHY VOLUNTEERS
Brief Summary ICH E14 recommends that a thorough QT/QTc (TQT) study should be performed to determine whether intensive monitoring of QT interval in target patient populations is required during later stages of development. The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation.
Detailed Description The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: CP-690,550
    Single dose 100 mg (5 x 20 mg tablets)
  • Drug: Placebo
    Single dose placebo tablets (5 tablets)
  • Drug: Moxifloxacin
    Single dose Avelox 400 mg tablet
Study Arms  ICMJE
  • Experimental: CP-690,550 100 mg
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin hydrochloride
    Intervention: Drug: Moxifloxacin
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
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 9, 2008
Actual Primary Completion Date February 7, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Use of tobacco- or nicotine-containing products in excess of equivalent of 5 cigarettes per day.
  • 12-lead ECG demonstrating QTc >450 msec or other clinically significant abnormalities at Screening.
  • History of risk factors for QT prolongation or torsades de pointes.
  • Pregnant or nursing women; women of childbearing potential unwilling or unable to use an acceptable method of nonhormonal contraception from at least 14 days prior to first dose until completion of follow-up.
  • Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to first dose of trial medication.
  • Any clinically significant infections within past 3 months or evidence of infection in past 7 days.
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 Belgium,   Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743677
Other Study ID Numbers  ICMJE A3921028
2007-004492-19 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP