This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
* To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects * To explore the pharmacodynamics of single or multiple dose of CJ-15314 phosphate in healthy male subjects * To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
A dose as CJ-15314, 1 capsule
B dose as CJ-15314, 1 capsule
C dose as CJ-15314, 1 capsule
Seoul National University Hospital, Dept. of Clinical Pharmacology
Seoul, South Korea
RECRUITINGCmax of single dose of CJ-15314
Time frame: Up to 72 hours
Tmax of single dose of CJ-15314
Time frame: Up to 72 hours
AUClast of single dose of CJ-15314
Time frame: Up to 72 hours
AUCinf of single dose of CJ-15314
Time frame: Up to 72 hours
t1/2 of single dose of CJ-15314
Time frame: Up to 72 hours
λz of single dose of CJ-15314
Time frame: Up to 72 hours
CL/F of single dose of CJ-15314
Time frame: Up to 72 hours
Vd/F of single dose of CJ-15314
Time frame: Up to 72 hours
Ae of single dose of CJ-15314
Time frame: Up to 72 hours
fe of single dose of CJ-15314
Time frame: Up to 72 hours
CLR of single dose of CJ-15314
Time frame: Up to 72 hours
Cmax,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cmin,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
D dose as CJ-15314, 2 capsules
E dose as CJ-15314, 1 capsule
F dose as CJ-15314, 2 capsules
Placebo, 1 capsule
Placebo, 1 capsule
Placebo, 1 capsule
Placebo, 2 capsules
Placebo, 1 capsule
Placebo, 2 capsules
Cav,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
Tmax,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
AUCtau,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
t1/2 of multiple doses of CJ-15314
Time frame: Up to 72 hours
PTF of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ra of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ae of multiple doses of CJ-15314
Time frame: Up to 72 hours
fe of multiple doses of CJ-15314
Time frame: Up to 72 hours
CLR of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
λz of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours