Healthy, Obesity, Overweight
Conditions
Keywords
- Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms
Brief summary
PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.
Interventions
DRUGPF-04620110
Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.
DRUGPlacebo
Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.
Sponsors
Bristol-Myers Squibb
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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 * Body Mass Index (BMI) of 26.5 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, andc linical safety laboratory measurements. | Baseline to 2 weeks |
| To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects. | Baseline to 2 weeks |
| To characterize the effect of PF-04620110 on postprandial lipid metabolism measures. | Baseline to 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Glucose, insulin, and C-peptide excursions | Day -1 and Day 14 |
| To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. | Day -1 and Day 14 |
| Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin | Day -1 and Day 14 |
| Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY | Day -1 and Day 14 |
| Secondary Pharmacodynamic Endpoints in response to a liquid meal test | Day -1 and Day 14 |
| Triglyceride excursions | Day -1, Day 1, and Day 14 |
Countries
United States
Outcome results
None listed