Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib
NCT Number: NCT06461078
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Drug Kinetics
Interventions: DRUG: Radotinib HCl
Sponsor: Il-Yang Pharm. Co., Ltd.
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2025-06-30
Locations: Severance Hospital, Seoul, Korea, Republic of

Summary:
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib in Healthy Adults

Primary Outcome Measures: Cmax(Maximum concentration of drug in plasma), Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|AUClast(Area under the plasma drug concentration-time curve to last concentration) of Radotinib, Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours
Secondary Outcome Measures: AUCinf(Area under the plasma drug concentration-time curve from 0 to infinity) of Radotinib, Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|Tmax(Time to maximum plasma concentration) of Radotinib, Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|t1/2(Terminal elimination half-life) of Radotinib, Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|Vd/F(Apparent volume of distribution), CL/F(Apparent clearance) of Radotinib, Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|Cmax of Radotinib metabolites(M1, M2), Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|Tmaxof Radotinib metabolites(M1, M2), Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours|t1/2, metabolic ratio(AUClast of metabolite/AUClast of Radotinib) of Radotinib metabolites(M1, M2), Pre-dose(0 hour), after dose 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 18 hours, 24 hours, 32 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours