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

Sponsor:	Pfizer
Collaborator:	Bristol-Myers Squibb
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00959426

Purpose

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, pharmacokinetics, and pharmacodynamics, of multiple oral doses of PF-04620110.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 1 Placebo-Controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Multiple Escalating Oral Doses Of PF-04620110 In Otherwise Healthy Overweight And Obese Adult Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines 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, vital sign, andc linical safety laboratory measurements. [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: Yes ]
To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects. [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
To characterize the effect of PF-04620110 on postprandial lipid metabolism measures. [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. [ Time Frame: Day -1 and Day 14 ] [ Designated as safety issue: No ]
Secondary Pharmacodynamic Endpoints in response to a liquid meal test [ Time Frame: Day -1 and Day 14 ] [ Designated as safety issue: No ]
Triglyceride excursions [ Time Frame: Day -1, Day 1, and Day 14 ] [ Designated as safety issue: No ]
Glucose, insulin, and C-peptide excursions [ Time Frame: Day -1 and Day 14 ] [ Designated as safety issue: No ]
Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY [ Time Frame: Day -1 and Day 14 ] [ Designated as safety issue: No ]
Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin [ Time Frame: Day -1 and Day 14 ] [ Designated as safety issue: No ]

Enrollment:	71
Study Start Date:	August 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-04620110	Drug: PF-04620110 Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.
Placebo Comparator: Placebo Comparator	Drug: Placebo Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.

Arms

Assigned Interventions

Experimental: PF-04620110

Drug: PF-04620110

Multiple oral doses of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned Initial planned doses are 1, 3, 5, 10 and 20 mg but may be modified based on emerging PK and safety data.

Placebo Comparator: Placebo Comparator

Drug: Placebo

Subjects will be given placebo or PF-04620110. Anticipated total daily doses for Cohorts A, B, C, D, E, F and G are 1, 3, 5, 10 and 20 mg. In each Cohort 9 subjects will receive active treatment and 3 will receive placebo for 14 days. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses during the study based on ongoing safety, tolerability and PK results, but will not be projected to exceed established PK stopping criteria.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959426

Locations

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

Sponsors and Collaborators

Pfizer

Bristol-Myers Squibb

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00959426 History of Changes
Other Study ID Numbers:	B0961002
Study First Received:	August 12, 2009
Last Updated:	June 3, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

- Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012