Healthy
Conditions
Brief summary
A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group, Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects
Interventions
DRUGPF-06650833
Suspension
DRUGPlacebo
Suspension
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy female subjects of non childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. 2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). 3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. Any condition possibly affecting drug absorption (eg, gastrectomy). 3. A positive urine drug screen. 4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening. 5. Smokers must not exceed the equivalent of 5 cigarettes per day. 6. 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). 7. Screening supine blood pressure100 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. If blood pressure (BP) is 40 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subject's eligibility. 8. Screening pulse or heart rate (HR) \>100 bpm after at least 5 minutes of rest. If the pulse/HR is \>100 bpm, the pulse/HR should be repeated two more times (separated by at least 2 minutes) and the average of the three pulse/HR values should be used to determine the subject's eligibility. 9. Screening 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility. 10. Clinically significant abnormality on chest X ray performed at screening or within 3 months of screening date. 11. History of tuberculosis or active or latent or inadequately treated infection, positive Quantiferon TB test 12. History of hepatitis or HIV, positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HepBsAg), hepatitis B core antibodies (HepBcAb) or hepatitis C antibodies (HCVAb).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in Herpes simplex virus-1 and -2 [HSV-1 and HSV-2] | 50 days |
| Incidence and Magnitude of Participants with Treatment-emergent chemistry abnormalities (including, cardiac enzymes CK, CK-MB and cardiac Troponin-1, serum myoglobin) | 50 days |
| Incidence and Magnitude of Participants with Treatment-emergent urinalysis abnormalities | 50 Days |
| Changes from baseline in blood pressure | 50 days |
| Changes from baseline in pulse rate | 50 days |
| Changes from baseline in respiratory rate | 50 days |
| Changes from baseline in ECG parameters (standard 12-lead ECG) | 50 days |
| Changes from baseline in Epstein-Barr virus [EBV] | 50 days |
| Changes from baseline in Cytomegalovirus [CMV] | 50 days |
| Incidence and Magnitude of Participants with Treatment-emergent hematology clinical abnormalities | 50 days |
| Incidence and severity of treatment emergent adverse events. | 50 days |
Secondary
| Measure | Time frame |
|---|---|
| To determine PF-06650833 excreted unchanged (AE tau and AE tau %), | Day 14 |
| To characterize Tmax in plasma | Day 1 and Day 14 |
| To characterize AUC tau in plasma | Day 1 and Day 14 |
| To characterize Cmin in plasma | Day 1 and Day 14 |
| Characterize Cmax (dose normalized) in plasma | Day 1 and Day 14 |
| To characterize AUC tau(dose normalized) in plasma | day1 and day 14 |
| To determine the renal clearance (CLr) | Day 14 |
| To characterize Cmax in plasma | Day 1 and Day 14 |
Countries
United States
Outcome results
None listed