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Completed

NCT Number: NCT00959426

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

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.

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Key information

Conditions

Obesity Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04620110

Drug

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

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2009
Registry last updated
Jun 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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