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
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
15
200 mg tablet administered twice per day for 14 days
2mg administered as single doses on Days 0 and 11
Placebo administered twice per day for 14 days
Pfizer Investigational Site
Chula Vista, California, United States
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Single Dose
Time frame: 0 - 10 hrs postdose
Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau)
Single Dose
Time frame: 0 - 10 hrs postdose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Single Dose
Time frame: 0 - 10 hrs postdose
Maximum Observed Plasma PF-05175157 Concentration (Cmax)
Steady State
Time frame: 0 - 48 hours postdose
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157
Steady State
Time frame: 0 - 48 hours postdose
Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax)
Steady State
Time frame: 0 - 48 hours postdose
Apparent Oral Clearance of PF-05175157 (CL/F)
Time frame: 0 - 48 hours postdose
Accumulation Ratio of PF-05175157 (Rac)
Time frame: 0 - 10 hours postdose
Plasma Decay Half-Life of PF-05175157 (t1/2)
Time frame: 0 - 48 hours postdose
Apparent Volume of Distribution of PF-05175157 (Vz/F)
Time frame: 0 - 48 hours postdose
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2mg administered as single doses on Days 0 and 11
Urinary Recovery for PF-05175157 (AE24)
Amount of PF-05175157 recovered in urine over 24 hours
Time frame: 0 - 24 hours postdose
Renal Clearance for PF-05175157 (CLr)
Time frame: 0 - 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)]
Time frame: 0 - 48 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)]
Time frame: 0 - 48 hours postdose
Maximum Observed Plasma Concentration for midazolam (Cmax)
Time frame: 0 - 48 hours postdose
Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax)
Time frame: 0 - 48 hours post dose
Plasma Decay Half-Life of midazolam (t1/2)
Time frame: 0 - 48 hours postdose
Fasting triglycerides
Time frame: 14 days
Total cholesterol
Time frame: 14 days
LDL cholesterol
Time frame: 14 days
HDL cholesterol
Time frame: 14 days