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A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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 subjects and/or healthy female subjects of non-childbearing potential
between the ages of 18 and 55 years, inclusive

- Body Mass Index (BMI) of 17.5 to 30.5 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

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

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

- History or family history of risk factors for QTc interval prolongation or torsades de
pointes (eg, organic heart disease, congestive heart failure, hypokalemia,
hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction);
family history of sudden death.

NCT00926263
Pfizer
Terminated
A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects

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A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
A Phase 1, Open Label Study To Evaluate The Pharmacokinetics, Pharmacodynamics, And Effect On QT/QTc Interval For CP-751,871 Following Single Intravenous Administration To Healthy Adult Subjects
This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.
This study was terminated on October 30th, 2009. While the study was terminated due to adverse events and altered benefit/risk ratio in healthy subjects, the findings in healthy volunteers are not considered to alter the benefit/risk evaluation of figitumumab in cancer patients. No changes due to the termination of this study are anticipated in the conduct of the ongoing cancer patient studies with figitumumab at this time.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy Volunteers
  • Biological: CP-751,871
    single dose, 1-hr IV infusion
  • Biological: CP-751,871, moxifloxacin, saline
    Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion
  • Experimental: 10 mg/kg cohort
    Intervention: Biological: CP-751,871
  • Experimental: 20 mg/kg cohort
    Intervention: Biological: CP-751,871
  • Experimental: 20/20 mg/kg cohort
    Intervention: Biological: CP-751,871, moxifloxacin, saline
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects and/or healthy female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • 12-lead ECG demonstrating QTc >450 msec at screening or other clinically significant abnormalities at screening.
  • History or family history of risk factors for QTc interval prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction); family history of sudden death.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
Belgium
 
NCT00926263
A4021037
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the

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

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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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[email protected]



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