Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders
Conditions
Brief summary
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.
Interventions
DRUGPf-05175157
200-mg administered twice daily for 14 days
DRUGplacebo
placebo administered twice daily for 14 days
DRUGmidazolam
midazolam 3-mg admistered as single doses on Day 0 and Day 11.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). * Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
* 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). * Evidence or history of any chronic ongoing or current pulmonary disease. * History of smoking in the past 5 years and a history of smoking more than 10 pack years, or history or evidence of habitual use of other (non smoked) tobacco or nicotine containing products. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours |
| Maximum Observed Plasma Concentration (Cmax) | 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) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hrs postdose |
| Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose |
| Apparent Volume of Distribution (Vz/F) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose |
| Apparent Oral Clearance (CL/F) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours postdose |
| Accumulation Ratio (Rac) | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hours postdose |
| Ae,tau | 0-12 hr |
| Ae% | 0-12 hr |
| Clr | 0-12 hr |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours |
| fasting triglycerides | 14 days |
| fasting LDL-cholesterol | 14 days |
| fasting total cholesterol | 14 days |
| fasting HDL cholesterol | 14 days |
Countries
United States
Outcome results
None listed