A Phase 1 interventional study of PF-06263726 and PF-06263726 in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-17.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy subjects.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PF-06263726
Drug: PF-06263726
Drug: PF-06263726
Drug: Placebo
Drug: PF-06263726
Drug: Placebo
Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
Subjects will receive dose strength of 4% PF-06263276 (2.28 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
Draize toxicity assessment score.
Changes from baseline on Draize toxicity assessment score.
Time frame: Day 8, Day 28
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) and physical examinations.
Time frame: Day 23, Day 28
Changes from baseline in 12 lead electrocardiogram (ECG) parameters.
Quantitative changes in ECG intervals.
Time frame: Day 23, Day 28
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events.
Time frame: Day 23, Day 28
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology, chemistry, fasting glucose, urinalysis.
Time frame: Day 23, Day 28
Cohorts 3 and 4: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1, Day 14
Cohorts 3 and 4: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1, Day 14
Cohorts 3 and 4: Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: Day 1, Day 14
Cohorts 3 and 4: Dose-Normalized Area Under the Curve From Time Zero to 12 hours [AUC (0-12)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: Day 1, Day 14
Cohorts 3 and 4: Dose-Normalized Maximum Observed Plasma Concentration [Cmax (dn)]
Time frame: Day 1, Day 14
Cohorts 3 and 4: Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: Day 14
Cohorts 3 and 4: Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: Day 14
Cohorts 3 and 4: Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: Day 14
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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