CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects

NCT03713892 | Unknown Phase 1

• 1 other identifier: 175MAD17021
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects

Conditions

Huntington Disease

Outcome Measures

Primary Outcomes (2)

• Cmax of CKD-504

  Peak Plasma Concentration (Cmax) of CKD-504

  Day1, Day2, Day3, Day4

• AUC of CKD-504

  Area under the plasma concentration versus time curve (AUC) of CKD-504

  Day1, Day2, Day3, Day4

Study Arms (2)

CKD-504

EXPERIMENTAL

investigational Drug

Drug: CKD-504

Placebo

PLACEBO COMPARATOR

investigational Drug

Drug: Placebo

Interventions

CKD-504 DRUG

orally administered once with investigational drug assigned on 1d morning with 240 mL of water

Also known as: HDAC inhibitor

CKD-504

Placebo DRUG

orally administered

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
• Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
• Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
• Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.

You may not qualify if:

• Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
• Subjects with a history of drug abuse or a positive urine screening for drug abuse.
• Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
• Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
• Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Huntington Disease

Interventions

CKD-504; Histone Deacetylase Inhibitors

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Kyung-Sang Yu

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Ji Song

CONTACT

82-2-3149-7853; songmj@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: May 23, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)