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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03308110

Enrollment

Registered

2017-10-12

Start date

2017-09-08

Completion date

2018-01-11

Last updated

2019-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGPF-06650833

Two formulations of PF-006650833

Study design

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cmax	0-96 hours
AUClast	0-96 hours

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026