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A Randomized, Double-blind/Open-label, Placebo/Active-controlled, Single/Multiple Dose, Parallel, Phase 1/2a Trial to Evaluate the Safety, Tolerability, PK , PD of YH12852 in Healthy Subjects and Patients With Functional Constipation
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
Details
| Lead sponsor | Yuhan Corporation |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2015-08 |
| Completion | 2016-09 |
Conditions
- Functional Constipation
Interventions
- YH12852 IR 0.05mg
- YH12852 IR 0.1mg
- YH12852 IR 0.3mg
- YH12852 IR 0.5mg
- YH12852 IR 1mg
- YH12852 IR 2mg
- YH12852 IR 3mg
- YH12852 DR1 0.5mg
- YH12852 DR1 1mg
- YH12852 DR1 2mg
Primary outcomes
- Cmax (IR/DR multiple dose cohort and Multiple low-dose IR cohort) — Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
- AUC0-24 (IR/DR multiple dose cohort and Multiple low-dose IR cohort) — Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
- Tmax(IR/DR multiple dose cohort and Multiple low-dose IR cohort) — Day 1 pre-dose (0 hr) ~ 24 hrs post-dose
- C(IR multiple dose cohort) — Day 5, 10, 12 and 13
CD5, CD10, CD12, CD13 - Cmax,ss(IR/DR multiple dose cohort and Multiple low-dose IR cohort) — Day 14
- Cmax,ss (DR single dose cohort) — Day 1: pre-dose (0 hr) ~ 62hr and 86 hrs post-dose
Countries
South Korea