Clinical trial NCT02609139: Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects
Official title: A Phase 1, Open Label, Single-Dose, Within Cohort Randomized, 2-Way Crossover Study To Evaluate The Pharmacokinetics Of A Modified Release Formulation Of Pf-06650833 Under Fasting And Fed Conditions In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: This is the third study of PF-06650833. The goals of the study are to assess the PK in healthy subjects of single doses of modified release (MR) tablets of PF-06650833 when orally administered under fasting and high fat meal fed conditions.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
2. Any condition possibly affecting drug absorption
3. Positive urine drug screen.
4. Heavy smokers
5. History of regular heavy alcohol consumption within 6 months of Screening.
6. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives
7. 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.
8. Screening pulse (HR) \>100 bpm after at least 5 minutes of rest.
9. Single supine 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening.
10. Abnormal chest X ray
11. History of TB or active or latent or inadequately treated infection, positive Quantiferon TB test.
12. History of hepatitis or positive testing for human HIV,HepBsAg, HepBc Ab or HCVAb
13. Any medical history of disease \[ie, Gilbert's disease\] that has the potential to cause a rise in total bilirubin over the ULN
14. 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).
15. 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.
16. 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.
17. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
18. History of sensitivity to heparin or heparin induced thrombocytopenia.
19. History of cancer (other than treated basal cell and squamous cell carcinoma of the skin) in the previous 5 years.
20. Previous exposure to PF 06650833.
21. Unwilling or unable to comply with the Lifestyle guidelines
22. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
23. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality

Primary outcomes:
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833 (if data permit)
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
Secondary outcomes:
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Plasma pharmacokinetic parameters of PF-06650833
timeFrame: Baseline for up to Day 14 (0 to +1) postdose
measure: Treatment emergent adverse events and withdrawals
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Vital signs
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Electrocardiogram parameters
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
measure: Clinical laboratory measurement
timeFrame: Baseline to up to Day 14 (0 to +1) postdose
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: