Skip to main content
OpenTrials
Completed

NCT Number: NCT02163161

AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Fasting Feeding Behavior Genetic Diseases, Inborn Hypoalphalipoproteinemias Hypolipoproteinemias Lecithin Cholesterol Acyltransferase Deficiency Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors 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

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects and female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
  • Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.

Treatment and study plan

PF-04965842

Drug

Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions

PF- 04965842

Drug

Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions

Primary outcomes

  1. Area Under the Curve from Time Zero to infinity (AUC inf)

    Time frame: 15 days

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 15 days

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

    Time frame: 15 days

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

Secondary outcomes

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

    Time frame: 15 days

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

    Time frame: 15 days

    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, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2014
Registry last updated
Aug 18, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.