This study is designed to assess the safety, tolerability and pharmacokinetics of multiple oral 200-mg doses of Pf-05175157 administered twice daily for 14 days in healthy overweight and obese subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
12
200-mg administered twice daily for 14 days
placebo administered twice daily for 14 days
midazolam 3-mg admistered as single doses on Day 0 and Day 11.
Pfizer Investigational Site
South Miami, Florida, United States
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Apparent Volume of Distribution (Vz/F)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Apparent Oral Clearance (CL/F)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose
Accumulation Ratio (Rac)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose
Ae,tau
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Time frame: 0-12 hr
Ae%
Time frame: 0-12 hr
Clr
Time frame: 0-12 hr
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours
fasting triglycerides
Time frame: 14 days
fasting LDL-cholesterol
Time frame: 14 days
fasting total cholesterol
Time frame: 14 days
fasting HDL cholesterol
Time frame: 14 days