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Completed

NCT Number: NCT03308110

Bioavailability and Food Effect Study of Two Formulations of PF-06650833

Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

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 female subjects of nonchild bearing potential and/or male subjects who, at the time of screening, are 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 lb).

Exclusion criteria

  • Subjects with any of the following characteristics/conditions will not be included in the study:

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

Any condition possibly affecting drug absorption (eg, gastrectomy).

  • A positive urine drug test.
  • History of regular alcohol consumption within 6 months before screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
  • Screening supine BP greater than equal to 140 mm Hg (systolic) or more than equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential;
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON-TB Gold test.

History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).

-Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality

Treatment and study plan

PF-06650833

Drug

Two formulations of PF-006650833

Primary outcomes

  1. Cmax

    Time frame: 0-96 hours

  2. AUClast

    Time frame: 0-96 hours

Secondary outcomes

  1. Cmax under high fat meal fed conditions

    Time frame: 0-96 hours

  2. Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)

    Time frame: 0-96 hours

  3. AUClast under high fat meal fed conditions

    Time frame: 0-96 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, SINGLE DOSE, OPEN LABEL, RANDOMIZED, 5-PERIOD CROSSOVER STUDY TO EVALUATE THE RELATIVE BIOAVAILABILITY AND FOOD EFFECT ON NEW MODIFIED RELEASE TABLET OF PF-06650833 IN HEALTHY SUBJECTS

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 12, 2017
Registry last updated
Apr 19, 2019

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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