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

Last updated on November 14, 2019

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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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Descriptive Information
Brief Title  ICMJE A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
Official Title  ICMJE 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
Brief SummaryThis study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.
Detailed DescriptionThis 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 9, 2009)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2009)
72
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion DateMay 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 CountriesBelgium
 
Administrative Information
NCT Number  ICMJE NCT00926263
Other Study ID Numbers  ICMJE A4021037
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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