Status:
COMPLETED
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Bioavailability and food effect of 2 formulations of PF-06650833 in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03308110
Start Date
September 8 2017
End Date
January 11 2018
Last Update
April 19 2019
Active Locations (1)
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1
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070