Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects
NCT02974374
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy males and female of non-childbearing potential;
- Body Mass Index 21.5 to 30.5 kg/m2 (inclusive);
- Total body weight >50 kg (110 lbs).
-Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
(including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the
time of dosing).
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Descriptive Information | ||||
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Brief Title ICMJE | Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects | |||
Official Title ICMJE | A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability And Pharmacokinetics Of Single, Escalating, Oral Doses Of Pf-06835919 In Healthy Adult Subjects | |||
Brief Summary | The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a single dose of PF-06835919 in healthy adult subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Masking: Double (Participant, Care Provider) Primary Purpose: Treatment | |||
Condition ICMJE | Non-alcoholic Fatty Liver Disease | |||
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 | 16 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2017 | |||
Actual Primary Completion Date | January 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: -Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). | |||
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 | NCT02974374 | |||
Other Study ID Numbers ICMJE | C1061001 | |||
Has Data Monitoring Committee | Not Provided | |||
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 | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |