Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted and high fat meal fed conditions in healthy subjects.

Key facts

Study ID

NCT02609139

Run by

Pfizer

People needed

18

Starts

2015-11-01

Expected to finish

2016-02-01

Last updated by the study team

2016-05-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy female subjects of non childbearing potential and/or male subjects, between the ages of 18 and 55 years
• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• Personally signed and dated Informed Consent
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Any condition possibly affecting drug absorption
• Positive urine drug screen.
• Heavy smokers
• History of regular heavy alcohol consumption within 6 months of Screening.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives
• Screening supine blood pressure <=100 mm Hg (systolic) or<=50 mm Hg (diastolic) or>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
• Screening pulse (HR) >100 bpm after at least 5 minutes of rest.
• Single supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
• Abnormal chest X ray
• History of TB or active or latent or inadequately treated infection, positive Quantiferon TB test.
• History of hepatitis or positive testing for human HIV,HepBsAg, HepBc Ab or HCVAb
• Any medical history of disease [ie, Gilbert's disease] that has the potential to cause a rise in total bilirubin over the ULN
• Clinical laboratory abnormalities including:
• Creatine kinase >1.2 X ULN;
• CK MB > ULN;
• Serum myoglobin >1.2 X ULN;
• Cardiac Troponin I (cTn I) > ULN of the laboratory reference range;
• Serum aspartate transaminase (AST) or alanine transaminase (ALT) >=2 x ULN, total serum bilirubin >=1.5 mg/dL;
• Subjects with benign ethnic neutropenia;
• Hemoglobin <=14 gm/dl (males) and <=13 gm/dL (females).
• Nursing female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the last dose of investigational product or longer based upon the compound's half life characteristics.
• 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 until discharge from the study at the end of Period 2.
• Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of investigational product. Acetaminophen/paracetamol should not be used. As an exception, ibuprofen may be used at doses of 200 to 400 mg orally every 6 hours as needed for up to 3 of 7 consecutive days.
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

Where it is running

• New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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