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Completed

NCT Number: NCT01146327

A Multiple Dose Study Of PF-04620110 In Healthy Overweight Or Obese Subjects

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

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Key information

Conditions

Healthy Body Weight 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, Brussels, Belgium

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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 5 mg of PF-04620110 will be given once daily for 2 weeks.

Placebo

Drug

Multiple oral doses of placebo will be given once daily for 2 weeks.

Primary outcomes

  1. To evaluate additional pharmacodynamic markers in response to multiple oral doses of PF-04620110.

    Time frame: Day 1 to Day 13

  2. To evaluate secondary Pharmacodynamic Endpoints in response to a liquid meal test in response to multiple oral doses of PF-04620110.

    Time frame: Day 6 and Day 14

Secondary outcomes

  1. To characterize the PK of PF-04620110 following multiple oral doses in otherwise healthy overweight and obese subjects.

    Time frame: Baseline to 2 weeks

  2. To assess safety and tolerability of PF-04620110 will be assessed by physical examinations, adverse event monitoring, 12-lead ECGs, vital sign, and clinical safety laboratory measurements.

    Time frame: Baseline to 2 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase 1, Parallel, Randomized Trial To Assess The Effect Of Time Of Dosing On The Pharmacodynamics, Pharmacokinetics, Safety And Tolerability Of Multiple Oral Doses Of PF-04620110 In Otherwise Healthy Overweight Or Obese Adult Subjects

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2010
Registry last updated
Apr 19, 2011

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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