Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
Study Details
Study Description
Brief Summary
A randomized, placebo-controlled, dose-escalation, crossover study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 Subjects received 125 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 125 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. |
Drug: CG-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
Other Names:
Drug: CG-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
Other Names:
Other: PO 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
Other: IV 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
|
| Experimental: Cohort 2 Subjects received 250 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 375 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. |
Drug: CG-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
Other Names:
Drug: CG-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
Other Names:
Other: PO 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
Other: IV 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
|
| Experimental: Cohort 3 Subjects received 125 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 750 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. |
Drug: CG-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
Other Names:
Drug: CG-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
Other Names:
Other: PO 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
Other: IV 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- The Number of Participants Who Experienced Serious or Non-Serious Adverse Events [Up to 4 weeks for each dosing cohort]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 |
Sponsors and Collaborators
- CrystalGenomics, Inc.
Investigators
- Principal Investigator: SeungHwan Lee, Ph.D, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CG200750-1-01