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CP-690,550 Thorough QTc Study

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
Contact
1-800-718-1021
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.

NCT01743677
Pfizer
Completed
CP-690,550 Thorough QTc Study

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CP-690,550 Thorough QTc Study
A Phase 1, Randomized, Placebo- And Positive-Controlled Crossover Study To Determine The Effect Of Single-Dose CP-690,550 On QTc Interval In Healthy Volunteers
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.
The current study is designed to ascertain whether CP-690,550 is associated with QTc prolongation
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Healthy
  • 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
  • Experimental: CP-690,550 100 mg
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Moxifloxacin hydrochloride
    Intervention: Drug: Moxifloxacin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium,   Singapore
 
 
NCT01743677
A3921028
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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