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A Single Dose Study Of PF-04620110 In Healthy Subjects

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Pfizer Identifier:
First received: June 17, 2010
Last updated: August 18, 2010
Last verified: August 2010
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of PF-04620110.

Condition Intervention Phase
Drug: PF-04620110
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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-04620110 Under Fed/Fasted Conditions in Healthy Adult Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life [ Time Frame: following each treatment ]

Secondary Outcome Measures:
  • Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead electrocardiograms (ECGs), vital signs, and clinical safety laboratory measurements. [ Time Frame: before, during and following treatment ]

Enrollment: 12
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABCE, ACBD, BACD, BCAE, CABE and CBAD Drug: PF-04620110

The five treatments are:

A) single dose of 5 mg immediate release tablets in the fasted state; B) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fasted state; C) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fasted state; D) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fed state; E) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fed state.


Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 55 years
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01166217

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01166217     History of Changes
Other Study ID Numbers: B0961009
Study First Received: June 17, 2010
Last Updated: August 18, 2010

Keywords provided by Pfizer:
Single Dose Study in Healthy Subjects processed this record on April 28, 2017