A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects
A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects
1 other identifier
interventional
60
2 countries
2
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 safety and tolerability, and pharmacodynamics, of multiple oral doses of PF-04620110.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jun 2010
Typical duration for phase_1 healthy
2 active sites
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
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 16, 2010
CompletedFirst Posted
Study publicly available on registry
June 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedApril 19, 2011
April 1, 2011
7 months
June 16, 2010
April 18, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.
Day 1 to Day 13
To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.
Day 6 and Day 14
Secondary Outcomes (2)
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.
Baseline to 2 weeks
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.
Baseline to 2 weeks
Study Arms (2)
PF-04620110
EXPERIMENTALPlacebo Comparator
PLACEBO COMPARATORInterventions
Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects between the ages of 18 and 55 years
- Body Mass Index (BMI) of 26.5 to 35.5 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 (2)
Pfizer Investigational Site
Brussels, B-1070, Belgium
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2010
First Posted
June 17, 2010
Study Start
June 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
April 19, 2011
Record last verified: 2011-04