Clinical trial NCT05345912: Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, double-blind, placebo-controlled, dose-escalation, crossover study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration of CG200745 (Cmax)
timeFrame: 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
measure: Area Under the Concentration-Time Curve (AUC 0-72h)
timeFrame: 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
Secondary outcomes:
measure: The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
timeFrame: Up to 4 weeks for each dosing cohort
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: SeungHwan Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: