Topical Multiple Ascending Dose Study for PF-06423264

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NCT02778477

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Normal Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males and female of non-childbearing potential;

- Body Mass Index 17.5-35.5 kg/m2;

- Body weight >50 kg;

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: PF-06423264
    Multiple ascending dose of PF-06423264
  • Other: Placebo
    Multiple dose of placebo
    Other Name: Placebo comparator
Study Arms  ICMJE
  • Experimental: Part A_Cohort 1_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 1_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 2_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 2_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 3_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 3_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 4_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 4_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 5_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 5_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 6_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 6_Placebo
    Multiple dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part A_Cohort 7_Active
    Multiple ascending dose of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part A_Cohort 7_Placebo
    Multiple ascending dose of placebo
    Intervention: Other: Placebo
  • Experimental: Part B_Cohort 1_Active
    Multiple doses of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part B_Cohort 1_Placebo
    Multiple doses of placebo
    Intervention: Other: Placebo
  • Experimental: Part B_Cohort 2_Active
    Multiple doses of PF-06423264
    Intervention: Drug: PF-06423264
  • Placebo Comparator: Part B_Cohort 2_Placebo
    Multiple doses of placebo
    Intervention: Other: Placebo
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
 (submitted: June 20, 2017)		65
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2016)		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:

  • Healthy males and female of non-childbearing potential;
  • Body Mass Index 17.5-35.5 kg/m2;
  • Body weight >50 kg;

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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