A Single Dose Study Of PF-04620110 In Healthy Subjects
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
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jul 2010
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 20, 2010
August 1, 2010
1 month
June 17, 2010
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life
following each treatment
Secondary Outcomes (1)
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.
before, during and following treatment
Study Arms (1)
ABCE, ACBD, BACD, BCAE, CABE and CBAD
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2010
First Posted
July 20, 2010
Study Start
July 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 20, 2010
Record last verified: 2010-08