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

NCT05345912 | Completed Phase 1

• 1 other identifier: CG200750-1-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• The Number of Participants Who Experienced Serious or Non-Serious Adverse Events

  Up to 4 weeks for each dosing cohort

Study Arms (3)

Cohort 1

EXPERIMENTAL

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.

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

Cohort 2

EXPERIMENTAL

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.

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

Cohort 3

EXPERIMENTAL

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.

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

Interventions

CG-745 IV Solution DRUG

CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion

Also known as: CG200745

Cohort 1; Cohort 2; Cohort 3

CG-750 125mg capsule DRUG

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

Also known as: CG200750

Cohort 1; Cohort 2; Cohort 3

PO Placebo OTHER

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

Cohort 1; Cohort 2; Cohort 3

IV Placebo: 0.9 % normal saline OTHER

IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

N1-(3-(dimethylamino)propyl)-N8-hydroxy-2-((naphthalene-1-loxy)methyl)oct-2-enediamide; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• SeungHwan Lee, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind Study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled, dose-escalation, crossover study

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: April 26, 2022
• Study Start: December 16, 2019
• Primary Completion: September 18, 2020
• Study Completion: May 19, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

KR (1)