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 17.5-35.5 kg/m2;
- Body weight >50 kg;
- Evidence of history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergises, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)
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Descriptive Information | ||||
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Brief Title ICMJE | Topical Multiple Ascending Dose Study for PF-06423264 | |||
Official Title ICMJE | A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Doses Of Pf-06423264 Administered Topically To Sequential Cohorts Of Healthy Subjects With And Without Oily Skin | |||
Brief Summary | The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Masking: Double (Participant, Investigator) Primary Purpose: Basic Science | |||
Condition ICMJE | Normal Healthy | |||
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 | Terminated | |||
Actual Enrollment ICMJE | 65 | |||
Original Estimated Enrollment ICMJE | 96 | |||
Actual Study Completion Date ICMJE | May 23, 2017 | |||
Actual Primary Completion Date | May 23, 2017 (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 | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02778477 | |||
Other Study ID Numbers ICMJE | B7561002 2014-003736-39 ( EudraCT 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 | June 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |