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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00959426
First received: August 12, 2009
Last updated: June 3, 2010
Last verified: June 2010
  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 1

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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 26, 2014