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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT03308110

Collaborator

(none)

Enrollment

Location

Arm

4.1

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06650833	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 8, 2017

Actual Primary Completion Date :

Dec 8, 2017

Actual Study Completion Date :

Jan 11, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Relative Bioavailability Cohort Relative Bioavailability cohort	Drug: PF-06650833 Two formulations of PF-006650833

Arm

Intervention/Treatment

Other: Relative Bioavailability Cohort

Relative Bioavailability cohort

Drug: PF-06650833

Two formulations of PF-006650833

Outcome Measures

Primary Outcome Measures

Cmax [0-96 hours]
AUClast [0-96 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Clinical Research Unit	Brussels		Belgium	B-1070

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT03308110

Other Study ID Numbers:

B7921011
2017-002052-88

First Posted:

Oct 12, 2017

Last Update Posted:

Apr 19, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 19, 2019