Diabetes Mellitus Type 2
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 tablet administered twice per day for 14 days
DRUGMidazolam
2mg administered as single doses on Days 0 and 11
OTHERPlacebo
Placebo administered twice per day for 14 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: * 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). * Women must be of non childbearing potential. * Body Mass Index (BMI) of 25 to 35 kg/m2 inclusive; and a total body weight \>50 kg (110 lbs). * An informed consent document signed and dated by the subject. * 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 | Description |
|---|---|---|
| Maximum Observed Plasma PF-05175157 Concentration (Cmax) | 0 - 10 hrs postdose | Single Dose |
| Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) | 0 - 10 hrs postdose | Single Dose |
| Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) | 0 - 10 hrs postdose | Single Dose |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 | 0 - 48 hours postdose | Steady State |
| Apparent Oral Clearance of PF-05175157 (CL/F) | 0 - 48 hours postdose | — |
| Accumulation Ratio of PF-05175157 (Rac) | 0 - 10 hours postdose | — |
| Plasma Decay Half-Life of PF-05175157 (t1/2) | 0 - 48 hours postdose | — |
| Apparent Volume of Distribution of PF-05175157 (Vz/F) | 0 - 48 hours postdose | — |
| Urinary Recovery for PF-05175157 (AE24) | 0 - 24 hours postdose | Amount of PF-05175157 recovered in urine over 24 hours |
| Renal Clearance for PF-05175157 (CLr) | 0 - 24 hours post dose | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] | 0 - 48 hours postdose | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] | 0 - 48 hours postdose | — |
| Maximum Observed Plasma Concentration for midazolam (Cmax) | 0 - 48 hours postdose | — |
| Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) | 0 - 48 hours post dose | — |
| Plasma Decay Half-Life of midazolam (t1/2) | 0 - 48 hours postdose | — |
| Fasting triglycerides | 14 days | — |
| Total cholesterol | 14 days | — |
| LDL cholesterol | 14 days | — |
| HDL cholesterol | 14 days | — |
Countries
United States
Outcome results
None listed