Diabetes Mellitus, Type 2
Conditions
Keywords
Multiple Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects
Brief summary
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers
Interventions
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
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
* Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive * Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight \>50 kg (110 lbs.)
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). * Any condition possibly affecting drug absorption (e.g., gastrectomy). * History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening. * History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring | 2 weeks |
| Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145 | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL | 2 weeks |
| Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight | 2 weeks |
Countries
United States
Outcome results
None listed