Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
Phase 1
Completed
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Registration Number
- NCT01807377
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-05175157, Midazolam PF-05175157 Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157 PF-05175157, Midazolam Midazolam Day 0: Midazolam 2 mg administered alone Days 1-14: 200 mg PF-05175157 administered BID Day 11: Midazolam and PF-05175157 Placebo, Midazolam Placebo Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo Placebo, Midazolam Midazolam Day 0: Midazolam 2 mg administered alone Days 1-14: Placebo administered BID Day 11: Midazolam and Placebo
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma PF-05175157 Concentration (Cmax) 0 - 48 hours postdose Steady State
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 - 48 hours postdose Steady State
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 Extrapolated Infinite Time for midazolam [AUC (0 - inf)] 0 - 48 hours postdose Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Chula Vista, California, United States