A Randomized, Double Blind, Placebo-controlled, Dose-escalation, Crossover Study to Compare and Evaluate the Pharmacokinetics and Safety of 'CG-745 IV' Intravenous Formulation and 'CG-750' Capsule Formulation in Healthy Male Adults
Overview
- Phase
- Phase 1
- Intervention
- CG-745 IV Solution
- Conditions
- Healthy
- Sponsor
- CrystalGenomics, Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum Observed Plasma Concentration of CG200745 (Cmax)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Arms & Interventions
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.
Intervention: CG-745 IV Solution
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.
Intervention: CG-750 125mg capsule
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.
Intervention: PO Placebo
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.
Intervention: CG-745 IV Solution
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.
Intervention: CG-750 125mg capsule
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.
Intervention: PO Placebo
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.
Intervention: CG-745 IV Solution
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.
Intervention: CG-750 125mg capsule
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.
Intervention: PO Placebo
Outcomes
Primary Outcomes
Maximum Observed Plasma Concentration of CG200745 (Cmax)
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
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)
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
Plasma level vs. time profiles were plotted for each subject in linear or log/linear
Secondary Outcomes
- The Number of Participants Who Experienced Serious or Non-Serious Adverse Events(Up to 4 weeks for each dosing cohort)