Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345912
• Other study ID #: CG200750-1-01
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2019
• Est. completion date: May 19, 2021

Study information

• Verified date: April 2022
• Source: CrystalGenomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, placebo-controlled, dose-escalation, crossover study.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 19, 2021
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CrystalGenomics, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration of CG200745 (Cmax)	Plasma level vs. time profiles were plotted for each subject in linear or log/linear graphs.	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
Primary	Area Under the Concentration-Time Curve (AUC 0-72h)	Plasma level vs. time profiles were plotted for each subject in linear or log/linear	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	The Number of Participants Who Experienced Serious or Non-Serious Adverse Events		Up to 4 weeks for each dosing cohort