Multiple Dose Safety Tolerability, Pharmacokinetics And Midazolam Interaction In Healthy Overweight And Obese Subjects
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus Type 2
Intervention: PF-05175157 (Drug); Midazolam (Drug); Placebo (Other); Midazolam (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: A Phase 1 Placebo-Controlled Study To Assess Safety, Tolerability, Pharmacokinetics And Effect On Midazolam Pharmacokinetics Of Multiple Oral Doses Of PF-05175157 Administered In A Tablet Formulation In Otherwise Healthy Overweight And Obese Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Maximum Observed Plasma PF-05175157 Concentration (Cmax)Area Under the Curve from Time Zero to end of dosing interval for PF-05175157 (AUCtau) Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) Maximum Observed Plasma PF-05175157 Concentration (Cmax) Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for PF-05175157 Time to Reach Maximum Observed Plasma PF-05175157 Concentration (Tmax) Apparent Oral Clearance of PF-05175157 (CL/F) Accumulation Ratio of PF-05175157 (Rac) Plasma Decay Half-Life of PF-05175157 (t1/2) Apparent Volume of Distribution of PF-05175157 (Vz/F) Urinary Recovery for PF-05175157 (AE24) Renal Clearance for PF-05175157 (CLr) Area Under the Curve From Time Zero to Last Quantifiable Concentration for midazolam [AUC (0-t)] Area Under the Curve From Time Zero to Extrapolated Infinite Time for midazolam [AUC (0 - inf)] Maximum Observed Plasma Concentration for midazolam (Cmax) Time to Reach Maximum Observed Plasma midazolam Concentration (Tmax) Plasma Decay Half-Life of midazolam (t1/2) Fasting triglycerides Total cholesterol LDL cholesterol HDL cholesterol
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, Chula Vista, California 91911, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2013
Last updated: September 16, 2013
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