A Study Of PF-04620110 As A Modified-Release Formulation In Healthy Overweight Or Obese Subjects

Pfizer27 enrolled

Overview

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.

To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of PF-04620110 as a modified-release formulation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-04620110 or PlaceboDRUG

Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks

PF-04620110 or PlaceboDRUG

Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks

PF-04620110 or PlaceboDRUG

Repeat Arm 1 or Arm 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 27 to 35 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.

Locations (1)

Pfizer Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Safety and tolerability data: number of subjects with adverse events and Laboratory Test Values of Potential Clinical Importance, Changes fro baseline in pulse rate, blood pressure and ECG measurements over 14 days.

Time frame: 2 weeks

Profile of Pharmacokinetics: timeframe 0, 0.5, 1,2.5, 4.5, 6.5, 8.5, 10, 10.5, 11, 12.5, 14.5, 16.5 and 24 hr on Days 1 and 14. 24, 48, 72, 96, 120, 144 and 216 hrs post first dosing

Time frame: 2 weeks

PK parameters: Area under the Concentration-Time Curve (AUC), Maximum Observed Plasma Concentration (Cmax), Time to Reach Maximum Observed Plasma Concentration (Tmax), Apparent Oral Clearance (CL/F), Accumulation Ratios (Cmax,ss/Cmin,ss, AUC

Time frame: 2 weeks

(0-24,ss)/AUC(0-24,sd) andCmax,ss/Cmax,sd)

Time frame: 2 weeks

Glucose response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average glucose on Days 0 and 14; fasting plasma glucose

Time frame: 2 weeks

Insulin response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average insulin on Days 0 and 14; fasting plasma insulin

Time frame: 2 weeks

total GLP-1 response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average total GLP-1 on Days 0 and 14; fasting total GLP-1

Time frame: 2 weeks

net triglycerides response: 24-hour (AUC(0-24)/24), post-MMTT (AUC(0.5-4.5)/4), post-lunch (AUC(4.5-10.5)/6) and post-dinner (AUC(10.5-16.5)/6) weighted mean average net triglycerides on Days 0 and 14; fasting plasma net triglycerides

Data from ClinicalTrials.gov

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