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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00799006

Purpose

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.

Condition	Intervention	Phase
Overweight	Drug: Placebo Drug: PF-04620110	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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. [ Time Frame: 4 days/dose group ] [ Designated as safety issue: Yes ]
The single dose pharmacokinetics of PF-04620110 will be assessed [ Time Frame: 4 days/dose group ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary pharmacodynamic endpoints will include postprandial lipid metabolism measures [ Time Frame: 1 day/dose group ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	November 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Placebo Subjects will be given placebo or PF-04620110
PF-04620110: Experimental	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799006

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0961001
Study First Received:	November 25, 2008
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00799006 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Single Ascending Dose Study in Overweight subjects

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Overweight
Healthy

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Overweight

ClinicalTrials.gov processed this record on September 10, 2009