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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959426
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : June 7, 2010
Bristol-Myers Squibb
Information provided by:

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

Condition or disease Intervention/treatment Phase
Obesity Overweight Healthy Drug: PF-04620110 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]
  2. To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects. [ Time Frame: Baseline to 2 weeks ]
  3. To characterize the effect of PF-04620110 on postprandial lipid metabolism measures. [ Time Frame: Baseline to 2 weeks ]

Secondary Outcome Measures :
  1. To examine additional pharmacodynamic markers in response to multiple oral doses of PF-04620110. [ Time Frame: Day -1 and Day 14 ]
  2. Secondary Pharmacodynamic Endpoints in response to a liquid meal test [ Time Frame: Day -1 and Day 14 ]
  3. Triglyceride excursions [ Time Frame: Day -1, Day 1, and Day 14 ]
  4. Glucose, insulin, and C-peptide excursions [ Time Frame: Day -1 and Day 14 ]
  5. Gut hormone excursions- including active GLP-1, total amide GLP-1, ghrelin, GIP, and PYY [ Time Frame: Day -1 and Day 14 ]
  6. Additional Secondary Pharmacodynamic Endpoint: Fasting adiponectin [ Time Frame: Day -1 and Day 14 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959426

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00959426     History of Changes
Other Study ID Numbers: B0961002
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2010

Keywords provided by Pfizer:
- Mutliple Ascending Dose Study in Overweight Subjects - Body Weight - Signs and Symptoms

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms