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

A Phase 1, Randomized, Double-Blind, Parallel, Placebo-Controlled, Multiple-Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of A Modified-Release Formulation Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-04620110 or Placebo; Drug: PF-04620110 or Placebo; Drug: PF-04620110 or Placebo

Detailed Description

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
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg QD PF-04620110 or Placebo	Drug: PF-04620110 or Placebo; Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks; Drug: PF-04620110 or Placebo; Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks; Drug: PF-04620110 or Placebo; Repeat Arm 1 or Arm 2
Experimental: 5 mg BID PF-04620110 or Placebo	Drug: PF-04620110 or Placebo; Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks; Drug: PF-04620110 or Placebo; Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks; Drug: PF-04620110 or Placebo; Repeat Arm 1 or Arm 2
Experimental: Optional Arm, PF-04620110 or Placebo	Drug: PF-04620110 or Placebo; Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks; Drug: PF-04620110 or Placebo; Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks; Drug: PF-04620110 or Placebo; Repeat Arm 1 or Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	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	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	2 weeks
(0-24,ss)/AUC(0-24,sd) andCmax,ss/Cmax,sd)	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	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	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	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	2 weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: January 25, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Multiple Dose Study Overweight Healthy Subjects Body Weight Modified-Release Formulation
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: B0961011