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Completed

NCT Number: NCT01794364

Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

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Key information

Conditions

Healthy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

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 of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Treatment and study plan

PF-06291874

Drug

PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.

Placebo

Other

Correspondingly, placebo doses will be administered as suspension.

Primary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0-72/dose

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]

    Time frame: 0-72/dose

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0-72/dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0-72/dose

  5. Plasma Decay Half-Life (t1/2)

    Time frame: 0-72/dose

  6. Apparent Oral Clearance (CL/F)

    Time frame: 0-72/dose

  7. Apparent Volume of Distribution (Vz/F)

    Time frame: 0-72/dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2013
Registry last updated
Apr 4, 2013

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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