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First-In-Human Study Of PF-04958242 In Healthy Volunteers

Last updated on November 20, 2019

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Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
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
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy volunteers, male and female, ages 21-55

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

- No women of child-bearing potential, no risk factors for seizures, no risk factors for
QTc prolongation

NCT01159483
Pfizer
Completed
First-In-Human Study Of PF-04958242 In Healthy Volunteers

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Descriptive Information
Brief Title  ICMJE First-In-Human Study Of PF-04958242 In Healthy Volunteers
Official Title  ICMJE A Phase I, First-In-Human, Randomized, Subject And Investigator-Blind, Sponsor Open, Single Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pf-04958242 In Healthy Adult Volunteers
Brief SummaryPF-04958242 in single doses will be safe and well tolerated by healthy volunteers.
Detailed DescriptionTo test the safety, tolerability and pharmacokinetics of PF-04958242 in healthy volunteers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04958242
    oral PIB, single dose, 0.01 mg, 0.03 mg, 0.1 mg
  • Drug: PF-04958242

    oral PIB, single dose, 0.3 mg, 0.6 mg*, 1.0 mg*

    *Unlikely to be administered as expected to exceed exposure limits.

Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Drug: PF-04958242
  • Experimental: Cohort 2
    Intervention: Drug: PF-04958242
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: July 7, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion DateOctober 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy volunteers, male and female, ages 21-55

Exclusion Criteria:

  • No women of child-bearing potential, no risk factors for seizures, no risk factors for QTc prolongation
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 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 Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01159483
Other Study ID Numbers  ICMJE B1701001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2010

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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