Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects

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NCT02871037

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-254-6398
[email protected]
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1-800-254-6398

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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 17.5-30.5 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 Single Dose, Repeated Dose, and Conditional Food Effect Study of PF-05221304 in Healthy Subjects
Official Title  ICMJE A Phase 1, 3-part Study Of Pf-05221304 In Healthy Adults: Part 1 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Single, Escalating, Oral Doses; Part 2 - Randomized, Double-blind, Placebo-controlled Assessment Of Safety And Pharmacokinetics Of Repeated, Escalating, Oral Doses; Conditional Part 3 - Effect Of Food On The Pharmacokinetics Of Pf-05221304
Brief Summary The current study is the first clinical trial proposed with PF-05221304. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single and repeated doses of PF-05221304 to healthy adult subjects. The study may also evaluate effect of food on PK of PF-05221304.
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-05221304
    Single or repeated, escalating dose of PF-05221304
  • Other: Placebo
    single or repeated dose of placebo
Study Arms  ICMJE
  • Experimental: Part 1_Cohort 1_Active
    Single, escalating dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Part 1_Cohort 1_Placebo
    Single dose of Placebo
    Intervention: Other: Placebo
  • Experimental: Part 1_Cohort 2_Active
    Single, escalating dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Part 1_Cohort 2_Placebo
    Single dose of Placebo
    Intervention: Other: Placebo
  • Experimental: Part 2_Active
    Repeated, escalating doses of PF-05221304
    Intervention: Drug: PF-05221304
  • Placebo Comparator: Part 2_Placebo
    Repeated doses of placebo
    Intervention: Other: Placebo
  • Experimental: Part 3
    Single dose of PF-05221304 with and without food
    Intervention: Drug: PF-05221304
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
 (submitted: April 6, 2017)		96
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)		98
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 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 17.5-30.5 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871037
Other Study ID Numbers  ICMJE C1171001
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 May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP