The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
Pfizer Investigational Site
New Haven, Connecticut, United States
Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring
Time frame: 2 weeks
Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145
Time frame: 2 weeks
Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL
Time frame: 2 weeks
Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast