PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral doses of immediate release (IR) and modified release (MR) tablets in healthy, adult participants under fasted conditions. This is an open label, single dose, randomized, 2 period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Small molecule tablets in immediate release form
Small molecule tablets in modified release form
Pfizer Clinical Research Unit
Brussels, Belgium
Maximum Observed Plasma Concentration (Cmax) of PF-06700841
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Time to reach maximum observed plasma concentration (Tmax) of PF-06700841
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit
Time frame: pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose
Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval
Time frame: Pre-dose and 48 hours post-dose
Change from baseline in heart rate
Time frame: Pre-dose and 48 hours post-dose
Change from baseline in blood pressure
Time frame: Pre-dose and 48 hours post-dose
Change from baseline in pulse rate
Time frame: Pre-dose and 48 hours post-dose
Change from baseline in oral temperature
Time frame: Pre-dose and 48 hours post-dose
Number of participants with laboratory abnormalities
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and 48 hours post-dose
Number of participants with Treatment -Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
Time frame: Baseline to 48 hours post-dose