Healthy
Conditions
Brief summary
A randomized, placebo-controlled, dose-escalation, crossover study.
Detailed description
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.
Interventions
DRUGCG-745 IV Solution
CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
DRUGCG-750 125mg capsule
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
OTHERPO Placebo
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
OTHERIV Placebo: 0.9 % normal saline
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
Sponsors
CrystalGenomics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind Study
Intervention model description
A randomized, double-blind, placebo-controlled, dose-escalation, crossover study
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Subject who signed voluntarily the written agreement after understanding the purpose, contents, the properties and expected adverse effects of investigational product * Subject who is considered to be appropriate for the study according to the judgment of investigator based on physical examination, clinical laboratory test, electrocardiogram, vital sign and questionnaire Key
Exclusion criteria
* Subject with clinically meaningful and relevant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system and mental system * Subject with sensitive reaction in HDAC inhibitor or another drug * Subject who participated in another clinical trial or bioequivalent study with past 6 weeks * Subject who is not considered to be appropriate for the study according to the judgment of investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration of CG200745 (Cmax) | 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 | Plasma level vs. time profiles were plotted for each subject in linear or log/linear graphs. |
| Area Under the Concentration-Time Curve (AUC 0-72h) | 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 | Plasma level vs. time profiles were plotted for each subject in linear or log/linear |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Participants Who Experienced Serious or Non-Serious Adverse Events | Up to 4 weeks for each dosing cohort |
Countries
South Korea
Outcome results
None listed