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A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

Last updated on November 21, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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

- Male or female of non-childbearing potential

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

- Evidence of clinically-significant medical illness, history of seizures, any condition
possibly affecting drug absorption

NCT01530529
Pfizer
Completed
A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

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Descriptive Information
Brief Title  ICMJE A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
Official Title  ICMJE A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects
Brief SummaryThe purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-05180999
    Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
  • Drug: PF-05180999
    Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
  • Drug: PF-05180999
    Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
  • Drug: PF-05180999
    Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
Study Arms  ICMJE
  • Experimental: PF-05180999 Immediate-Release
    Intervention: Drug: PF-05180999
  • Experimental: PF-05180999 Modified-Release 1
    Intervention: Drug: PF-05180999
  • Experimental: PF-05180999 Modified-Release 2
    Intervention: Drug: PF-05180999
  • Experimental: PF-05180999 Modified-Release 1 With Food
    Intervention: Drug: PF-05180999
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: February 7, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion DateApril 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female of non-childbearing potential

Exclusion Criteria:

  • Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption
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 NCT01530529
Other Study ID Numbers  ICMJE B3441007
B3441007
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 DateApril 2012

ICMJE     Data element required by the

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

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