Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions
NCT02224651
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- Healthy male and/or 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).
- Screening supine blood pressure 100 mm Hg (systolic) or 50 mm Hg (diastolic); or 140
mm Hg (systolic) or 90 mm Hg (diastolic) following at least 5 minutes of supine rest.
If blood pressure (BP) is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should
be repeated two more times and the average of the three BP values should be used to
determine the subject's eligibility.
- Pulse or heart rate (HR) >100 bpm after at least 5 minutes of rest. If the pulse/HR is
>100 bpm, the pulse/HR should be repeated two more times (separated by at least 2
minutes) and the average of the three pulse/HR values should be used to determine the
subject's eligibility.
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Descriptive Information | ||||
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Brief Title ICMJE | Study to Evaluate Safety and Tolerability of Single Ascending Doses of Multiple Formulations of PF-06650833 in Healthy Subjects Under Fasted and Fed Conditions | |||
Official Title ICMJE | A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Substitution, Crossover, Single Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Pf 06650833 Delivered In Multiple Formulations In Healthy Subjects Under Fasted And Fed Conditions | |||
Brief Summary | This single ascending dose study is the first evaluation of PF-06650833 in humans. The goals are to assess the safety, tolerability and blood levels of ascending doses of multiple formulations of PF-06650833 and to perform a preliminary assessment of the effect of food on exposure, in healthy subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Danto SI, Shojaee N, Singh RSP, Li C, Gilbert SA, Manukyan Z, Kilty I. Safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06650833, a selective interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor, in single and multiple ascending dose randomized phase 1 studies in healthy subjects. Arthritis Res Ther. 2019 Dec 5;21(1):269. doi: 10.1186/s13075-019-2008-6. | |||
* 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 | 40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2015 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02224651 | |||
Other Study ID Numbers ICMJE | B7921001 IRAK4 FIH ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |