First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects
NCT03309241
Last updated date
ABOUT THIS STUDY
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study
of PF-06882961.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-254-6398
Eligibility Criteria
condition
Healthy Subjects
Sex
Females and Males
Age
18-55 years
Inclusion Criteria
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- - Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
- - Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
- - Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
Exclusion Criteria
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- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.- - Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
- - Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
- - Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose
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Advanced Information
Descriptive Information | |||||
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Brief Title ICMJE | First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects | ||||
Official Title ICMJE | A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects | ||||
Brief Summary | The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study of PF-06882961. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: Double-blind (sponsor open) Primary Purpose: Basic Science
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Condition ICMJE | Healthy Subjects | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Completed | ||||
Actual Enrollment ICMJE | 25 | ||||
Original Estimated Enrollment ICMJE | 24 | ||||
Actual Study Completion Date ICMJE | March 22, 2018 | ||||
Actual Primary Completion Date | February 21, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
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 | NCT03309241 | ||||
Other Study ID Numbers ICMJE | C3421001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | March 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |