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Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

Last updated on November 17, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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 male and/or females between the ages of 18 and 55 years inclusive

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

- Currently pregnant

NCT01753791
Pfizer
Completed
Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults

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Descriptive Information
Brief Title  ICMJE Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
Official Title  ICMJE A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults
Brief SummaryThe purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: 80 mg PF-06473871
    80 mg of PF-06473871 or placebo
  • Drug: 160 mg PF-06473871
    160 mg of PF-06473871 or placebo
  • Drug: 320 mg PF-06473871
    320 mg of PF-06473871 or placebo
  • Drug: 480 mg PF-06473871
    480 mg of PF-06473871 or placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Drug: 80 mg PF-06473871
  • Experimental: Cohort 2
    Intervention: Drug: 160 mg PF-06473871
  • Experimental: Cohort 3
    Intervention: Drug: 320 mg PF-06473871
  • Experimental: Cohort 4
    Intervention: Drug: 480 mg PF-06473871
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: December 17, 2012)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion DateJune 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or females between the ages of 18 and 55 years inclusive

Exclusion Criteria:

  • Currently pregnant
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 NCT01753791
Other Study ID Numbers  ICMJE B5301002
2012-003797-13 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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