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

• ClinicalTrials.gov Identifier: NCT03308110
• Recruitment Status: Completed
• First Posted: October 12, 2017
• Last Update Posted: April 19, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: September 5, 2017
• First Posted Date: October 12, 2017
• Last Update Posted Date: April 19, 2019
• Actual Study Start Date: September 8, 2017
• Actual Primary Completion Date: December 8, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2017)

• Cmax [ Time Frame: 0-96 hours ]
• AUClast [ Time Frame: 0-96 hours ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 6, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioavailability and Food Effect Study of Two Formulations of PF-06650833
• Official 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
• Brief Summary: Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Healthy

Intervention

Drug: PF-06650833

Two formulations of PF-006650833

Study Arms

Relative Bioavailability Cohort

Relative Bioavailability cohort

Intervention: Drug: PF-06650833

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 6, 2017): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 11, 2018
• Actual Primary Completion Date: December 8, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03308110
• Other Study ID Numbers: B7921011; 2017-002052-88 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• 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.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: April 2019