Study To Estimate The Relative Bioavailability of PF-04971729 in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01114568
First received: April 27, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to examine the rate and extent of absorption of three oral formulations of PF 04971729 administered in lean to obese healthy volunteers.


Condition Intervention Phase
Healthy
Drug: PF 04971729
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04971729 in Lean To Obese, Otherwise Healthy Adult Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life [ Time Frame: 1 week (i.e. 3 x 48 hours) ] [ Designated as safety issue: No ]
  • Safety Endpoints: assessed by physical examinations, adverse event monitoring, fluid balance, 12 lead ECGs, vital sign, and clinical laboratory measurements [ Time Frame: 1 month (actually 3 x 1 week + 2 days) ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic Endpoints: Time course of the urinary glucose excretion over the intervals of 0 4 hour, 4 8 hour, 8 12 hour, 12 24 hour, 24 36 hour and 36 48 hour postdose. [ Time Frame: 1 week (i.e. 3 x 48 hours) ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3-period, 6 sequence crossover study
The three formulations A), B) and C) will be administered as sequence: ABC, ACB, BAC, BCA, CAB and CBA
Drug: PF 04971729
Formulation A) PF 04971729 10 mg - administered as tablet
Drug: PF 04971729
Formulation B) PF 04971729 10 mg - administered as capsule
Drug: PF 04971729
Formulation C) PF 04971729 10 mg - administered as capsule

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 65 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
  • Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen at Screening or prior to dosing in Period 1.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  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: NCT01114568

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: NCT01114568     History of Changes
Other Study ID Numbers: B1521005
Study First Received: April 27, 2010
Last Updated: June 28, 2010
Health Authority: Singapore: Singapore Health Sciences Authority (HSA)

Keywords provided by Pfizer:
Relative Bioavailability
Pharmacokinetics
Pharmacodynamics

ClinicalTrials.gov processed this record on October 21, 2014