A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01366287
First received: January 4, 2011
Last updated: June 2, 2011
Last verified: June 2011
  Purpose

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-03882845
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Open-Label, Single Dose, Crossover Study To Estimate The Relative Oral Bioavailability And Food Effect Of PF-03882845 In Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit. [ Time Frame: predose and post each dose (24, 48 and 96 hour timepoints) ] [ Designated as safety issue: No ]
    Post dose is measured at 24, 48 and 96 hours after dose.

  • Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring. [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2011
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suspension/fasted Drug: PF-03882845
25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
Experimental: Tablet/fasted Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
Experimental: Tablet/fed Drug: PF-03882845
25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Serum potassium >5 mEq/L at screening.
  • Impaired kidney function (estimated GFR <60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.
  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: NCT01366287

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
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: NCT01366287     History of Changes
Other Study ID Numbers: B0171006
Study First Received: January 4, 2011
Last Updated: June 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Relative bioavailability
food effect
tablet
suspension
single dose
crossover
healthy subjects

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014