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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474941
• Other study ID #: B0961011
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2011
• Last updated: January 25, 2012
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

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
• PF-04620110 or Placebo
Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks
• PF-04620110 or Placebo
Repeat Arm 1 or Arm 2

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	(0-24,ss)/AUC(0-24,sd) andCmax,ss/Cmax,sd)		2 weeks	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

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