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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Formulation 1
Drug: Formulation 2
Drug: Formulation 3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Drug: Formulation 1
150-mg immediate release tablet (single dose)
Experimental: Formulation 2 Drug: Formulation 2
150-mg modified release capsule, short duration (single dose)
Experimental: Formulation 3 Drug: Formulation 3
150-mg modified release capsule, long duration (single dose)

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351129

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01351129     History of Changes
Other Study ID Numbers: B2611009
Study First Received: May 9, 2011
Last Updated: July 5, 2011
Health Authority: Singapore: Singapore Health Sciences Authority (HSA)

Keywords provided by Pfizer:
formulation comparison

ClinicalTrials.gov processed this record on September 30, 2014