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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01530529
First received: February 7, 2012
Last updated: April 29, 2012
Last verified: April 2012

February 7, 2012
April 29, 2012
January 2012
April 2012   (final data collection date for primary outcome measure)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
Plasma pharmacokinetics - Maximum plasma concentration, time to reach maximum plasma concentration, area under the curve, and half-life [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01530529 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01530529
B3441007, B3441007
No
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