A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

Healthy Clinical Trial

Official title:

A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146327
• Other study ID #: B0961010
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2010
• Last updated: April 18, 2011
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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, and pharmacodynamics, of multiple oral doses of PF-04620110.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 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

• 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.

Study Design

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

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

Drug:
• PF-04620110
Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.
• PF-04620110
Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.
• PF-04620110
Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.
• PF-04620110
Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.
• Placebo
Multiple oral doses of placebo will be given once daily for 2 weeks.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Singapore	Pfizer Investigational Site	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Bristol-Myers Squibb

Countries where clinical trial is conducted

Belgium,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.		Day 1 to Day 13	No
Primary	To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.		Day 6 and Day 14	No
Secondary	To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.		Baseline to 2 weeks	No
Secondary	To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.		Baseline to 2 weeks	Yes

External Links

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