A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects
1 other identifier
interventional
27
1 country
1
Brief Summary
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2008
Shorter than P25 for phase_1
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
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJuly 20, 2009
July 1, 2009
7 months
November 25, 2008
July 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.
4 days/dose group
The single dose pharmacokinetics of PF-04620110 will be assessed
4 days/dose group
Secondary Outcomes (1)
Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures
1 day/dose group
Study Arms (2)
Placebo
PLACEBO COMPARATORPF-04620110
EXPERIMENTALInterventions
A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.
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 approximately 27 to 35 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Publications (1)
Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.
PMID: 36690550DERIVED
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
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 27, 2008
Study Start
November 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
July 20, 2009
Record last verified: 2009-07