Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04488900
Other study ID # A104-01DL2001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1