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

CrystalGenomics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: PO Placebo; Drug: CG-745 IV Solution; Drug: CG-750 125mg capsule; Other: IV Placebo: 0.9 % normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT05345912

CG200750-1-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Other: IV Placebo: 0.9 % normal saline

Drug: CG-750 125mg capsule

Drug: CG-745 IV Solution

Other: PO Placebo

Cohort 2

Experimental group

Description:

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.

Treatment:

Other: IV Placebo: 0.9 % normal saline

Drug: CG-750 125mg capsule

Drug: CG-745 IV Solution

Other: PO Placebo

Cohort 3

Experimental group

Description:

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.

Treatment:

Other: IV Placebo: 0.9 % normal saline

Drug: CG-750 125mg capsule

Drug: CG-745 IV Solution

Other: PO Placebo