Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488900
• Other study ID #: A104-01DL2001
• Status: Completed
• Phase: Phase 1
• Start date: July 6, 2020
• Est. completion date: July 2, 2023

Study information

• Verified date: February 2024
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
• Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
• Females of non-childbearing potential (surgically sterile [hysterectomy or oophorectomy] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
• Males must be unable to procreate (defined as surgically sterile [i.e., had a vasectomy =6 months prior to screening]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
• Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).

Exclusion Criteria:

• Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
• Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
• Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
• Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
• Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• CKD-508 Capsule
Investigational drug
• Placebo Capsule
Placebo
• CKD-508 Tablet
Investigational drug
• Placebo Tablet
Placebo

Locations

Country	Name	City	State
United Kingdom	Northwick Park Hospital	Harrow	Middlesex

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability including treatment-emergent AE and treatment-emergent SAE		28 days post the final dose
Secondary	Maximum plasma CKD-508 concentrations after dosing	Peak plasma concentration (Cmax)	28 days post the final dose
Secondary	Time of maximum plasma CKD-508 concentrations after dosing	Time of peak plasma concentration (Tmax)	28 days post the final dose
Secondary	Changes from baseline in plasma CKD-508 concentrations in time after dosing	Area under the plasma concentration versus time curve (AUC)	28 days post the final dose
Secondary	Changes from baseline in CETP activity after dosing	Pharmacodynamics endpoint	28 days post the final dose
Secondary	Changes from baseline in lipid parameters after dosing	including, but not limited to the following: LDL-C, etc.; Pharmacodynamics endpoint	14 days post the final dose