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Completed

NCT Number: NCT02208284

A Single Oral Dose Study Of PF-06427878 In Healthy Adult Subjects

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects.

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Key information

Conditions

Healthy Dyslipidemias Hyperlipidemias Lipid 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

New Haven Clinical Research Unit

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 35.4 kg/m2; and a total body weight >50 kg
  • Subjects with fasting TG level of >=90 mg/dL and <=500 mg/dL following an overnight fast

Exclusion criteria

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

Treatment and study plan

PF-06427878

Drug

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Placebo

Drug

PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.

Primary outcomes

  1. Assessment of adverse events (AEs).

    Time frame: 0-48 h post dose

  2. Assessment of clinical laboratory tests.

    Time frame: 0-48 h post dose

  3. Assessment of vital signs (including blood pressure and pulse rate).

    Time frame: 0-48 h post dose

  4. Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).

    Time frame: 0-48 h post dose

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).

  3. Maximum Observed Plasma Concentration (Cmax) for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

  5. Apparent Oral Clearance (CL/F) for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  6. Apparent Volume of Distribution (Vz/F) for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

  7. Plasma Decay Half-Life (t1/2) for PF-06427878

    Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06427878 Co-administered With Meal In Healthy Adult Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2014
Registry last updated
Mar 4, 2015

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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