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

Last updated on May 10, 2018

FOR MORE INFORMATION
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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A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
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
The 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01530529
B3441007
B3441007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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