A randomized, placebo-controlled, dose-escalation, crossover study.
Total of 24 health volunteers will be randomized to receive either of Cohort 1,2 or 3. (8 subjects each) \[Cohort 1\] Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated CG-750 capsule or placebo with 150 mL of water. \[Cohort 2\] The recommended dose of capsule in cohort 2 will be determined based on the bioavailabilty and safety data of cohort 1. Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 capsules or placebo with 150 mL of water. After 2-week rest period, subject will take the high fat diet and then be administrated the determined dose of CG-750 or placebo with 150 mL of water. \[Cohort 3\] The recommended dose of capsule in cohort 3 will be determined based on the bioavailabilty of cohort 1 and 2. Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
CG-750 capsule: Supplied as 125 mg/capsule Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3
PO Placebo: Supplied as placebo capsule (same appearance as in CG-750 Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3
Seoul National University Hospital
Seoul, South Korea
Maximum Observed Plasma Concentration of CG200745 (Cmax)
Plasma level vs. time profiles were plotted for each subject in linear or log/linear graphs.
Time frame: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose
Area Under the Concentration-Time Curve (AUC 0-72h)
Plasma level vs. time profiles were plotted for each subject in linear or log/linear
Time frame: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Time frame: Up to 4 weeks for each dosing cohort
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion