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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308110
• Other study ID #: B7921011
• Secondary ID: 2017-002052-88
• Status: Completed
• Phase: Phase 1
• Start date: September 8, 2017
• Est. completion date: January 11, 2018

Study information

• Verified date: April 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 11, 2018
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06650833
Two formulations of PF-006650833

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		0-96 hours
Primary	AUClast		0-96 hours
Secondary	Cmax under high fat meal fed conditions		0-96 hours
Secondary	Pharmacokinetic parameters of PF-06650833 from plasma concentration (if data permits)		0-96 hours
Secondary	AUClast under high fat meal fed conditions		0-96 hours

External Links

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