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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00926263 |
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Date of registration:
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21/06/2009 |
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Primary sponsor: |
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Public title:
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A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
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Scientific title:
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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 |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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28 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00926263 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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Belgium
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Biological: CP-751,871
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Biological: CP-751,871, moxifloxacin, saline
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Primary Outcome(s)
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Pharmacokinetic parameters of CP-751,871
[Time Frame: baseline to 12 weeks post dose]
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QTc using Fridericia's correction method at each postdose time point after receiving CP-751,871 at the 20/20 mg/kg dose level
[Time Frame: base line to 4 weeks post dose]
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Secondary Outcome(s)
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Adverse events, and abnormalities in clinical safety laboratory tests and vital signs
[Time Frame: baseline to 12 weeks post dose]
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Anti-drug antibodies against CP-751,871 in serum samples
[Time Frame: baseline to 12 weeks post dose]
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Measurements of IGF-axis related biomarkers
[Time Frame: baseline to 12 weeks post dose]
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QTcF after receiving moxifloxacin at the historical moxifloxacin median Tmax of 3 hours
[Time Frame: baeline to 3 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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