A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
120
Seoul National University Hospital
Seoul, South Korea
Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
C(IR multiple dose cohort)
CD5, CD10, CD12, CD13
Time frame: Day 5, 10, 12 and 13
Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort)
Time frame: Day 14
Cmax,ss (DR single dose cohort)
Time frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
AUClast (DR single dose cohort)
Time frame: Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
C(DR multiple dose cohort and Multiple low-dose IR cohort)
CD5, CD13, CD14
Time frame: Day 5, 13 and 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.