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Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01388829
First received: July 5, 2011
Last updated: August 9, 2011
Last verified: August 2011
History of Changes

July 5, 2011
August 9, 2011
July 2011
August 2011   (final data collection date for primary outcome measure)
  • Plasma AUClast [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours ] [ Designated as safety issue: No ]
  • Plasma Cmax [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01388829 on ClinicalTrials.gov Archive Site
Plasma Tmax [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532
A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of 2 Different Formulations Of PF-04991532

This study is designed to compare the pharmacokinetics of two different lots of tablets.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • Drug: Treatment A
    150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot
  • Drug: Treatment B
    150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot
Experimental: formulation comparison
formulation comparison
Interventions:
  • Drug: Treatment A
  • Drug: Treatment B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
  • 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 or a legally acceptable representative.

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.
  • Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement [confirmed by a single repeat, if necessary] following at least 5 minutes of rest.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01388829
B2611015
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

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