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

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ClinicalTrials.gov Identifier: NCT03713892
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: CKD-504 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CKD-504
investigational Drug
Drug: CKD-504
orally administered once with investigational drug assigned on 1d morning with 240 mL of water
Other Name: HDAC inhibitor

Placebo Comparator: Placebo
investigational Drug
Drug: Placebo
orally administered




Primary Outcome Measures :
  1. Cmax of CKD-504 [ Time Frame: Day1, Day2, Day3, Day4 ]
    Peak Plasma Concentration (Cmax) of CKD-504

  2. AUC of CKD-504 [ Time Frame: Day1, Day2, Day3, Day4 ]
    Area under the plasma concentration versus time curve (AUC) of CKD-504



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713892


Contacts
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Contact: SoMi Ahn 82-2-3149-7891 ahnsomi@ckdpharm.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyung-Sang Yu         
Principal Investigator: Kyung-Sang Yu         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Kyung-Sang Yu Seoul National University Hospital

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03713892     History of Changes
Other Study ID Numbers: 175MAD17021
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias