Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01351129
First received: May 9, 2011
Last updated: July 5, 2011
Last verified: July 2011

May 9, 2011
July 5, 2011
May 2011
June 2011   (final data collection date for primary outcome measure)
Area under the plasma concentration versus time profile (AUC) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01351129 on ClinicalTrials.gov Archive Site
  • Max observed plasma concentration (Cmax) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose ] [ Designated as safety issue: No ]
  • Time of Cmax (Tmax) [ Time Frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose ] [ Designated as safety issue: No ]
  • Concentration at 24 hours postdose (C24hr) [ Time Frame: 24 hrs postdose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers
A Phase 1, Single-Dose, Open-Label, Crossover Study To Estimate The Relative Bioavailability Of Two Controlled-Release Formulations Vs. An Immediate Release Formulation Of PF-04991532 In Healthy Adult Subjects

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Formulation 1
    150-mg immediate release tablet (single dose)
  • Drug: Formulation 2
    150-mg modified release capsule, short duration (single dose)
  • Drug: Formulation 3
    150-mg modified release capsule, long duration (single dose)
  • Experimental: Formulation 1
    Intervention: Drug: Formulation 1
  • Experimental: Formulation 2
    Intervention: Drug: Formulation 2
  • Experimental: Formulation 3
    Intervention: Drug: Formulation 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Both
21 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT01351129
B2611009
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP