Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
- Conditions
- Healthy
- Interventions
- Drug: CG-745 IV SolutionDrug: CG-750 125mg capsuleOther: PO Placebo
- Registration Number
- NCT05345912
- Lead Sponsor
- CrystalGenomics, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 CG-745 IV Solution 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. Cohort 1 CG-750 125mg capsule 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. Cohort 2 PO Placebo 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. Cohort 3 CG-750 125mg capsule 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. Cohort 2 CG-745 IV Solution 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. Cohort 1 PO Placebo 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. Cohort 3 CG-745 IV Solution 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. Cohort 2 CG-750 125mg capsule 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. Cohort 3 PO Placebo 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method The Number of Participants Who Experienced Serious or Non-Serious Adverse Events Up to 4 weeks for each dosing cohort
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of