A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers

Overweight Clinical Trial

Official title:

A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799006
• Other study ID #: B0961001
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2008
• Last updated: July 17, 2009
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics following a single oral dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• 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 approximately 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 disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Study Design

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

Related Conditions & MeSH terms

• Overweight

Intervention

Drug:
• Placebo
Subjects will be given placebo or PF-04620110
• PF-04620110
A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements.		4 days/dose group	Yes
Primary	The single dose pharmacokinetics of PF-04620110 will be assessed		4 days/dose group	No
Secondary	Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures		1 day/dose group	No

External Links

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