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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06650833

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Relative Bioavailability Cohort; Relative Bioavailability cohort	Drug: PF-06650833; Two formulations of PF-006650833

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	0-96 hours
AUClast	0-96 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax under high fat meal fed conditions	0-96 hours
Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)	0-96 hours
AUClast under high fat meal fed conditions	0-96 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2017
• Primary Completion (ACTUAL): December 8, 2017
• Study Completion (ACTUAL): January 11, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (ACTUAL): October 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: B7921011; 2017-002052-88 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No