A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy male volunteer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
IDP-73152 mesylate 40 mg single dose administration
IDP-73152 mesylate 80 mg single dose administration
IDP-73152 mesylate 160 mg single dose administration
Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Vital signs
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Electrocardiography
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Clinical laboratory tests
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Physical exam
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 day
Adverse event
Time frame: participants will be followed for the duration of hospital stay and post study visit, an expected average of 10 days
Cmax, Cmax/D, AUClast, AUClast/D, AUCinf, AUCinf/D of IDP-73152 mesylate
Time frame: Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)
Tmax, T1/2, CL/F, CLr of IDP-73152 mesylate
Time frame: Pre-dose (0 h), Post-dose (0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10,12, 24, 36, 48 h)
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IDP-73152 mesylate 320 mg single dose administration
IDP-73152 mesylate 640 mg single dose administration
IDP-73152 mesylate 1280 mg single dose administration
Placebo single dose administration