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Completed

NCT Number: NCT01064492

A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

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, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Women must be of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 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.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.

Treatment and study plan

PF-04620110

Drug

The three treatments are A) a single dose of 5 mg PIC under fasted condition; B) a single dose of 5 mg tablet under fasted condition: and C) a single dose of 5 mg tablet under fed condition.

Primary outcomes

  1. Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.

    Time frame: following each treatment

Secondary outcomes

  1. Safety Endpoints: 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: before, during, and following treatment

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2010
Registry last updated
Mar 18, 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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