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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
27
Subjects will be given placebo or PF-04620110
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.
Pfizer Investigational Site
New Haven, Connecticut, United States
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.
Time frame: 4 days/dose group
The single dose pharmacokinetics of PF-04620110 will be assessed
Time frame: 4 days/dose group
Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures
Time frame: 1 day/dose group
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