- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746287
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
May 2, 2022 updated by: Chong Kun Dang Pharmaceutical
First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects
This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects.
This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grenoble, France
- Clinical Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subject
- Non-smoker subject or light smoker
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive at screening
- Laboratory parameters within the normal range of the laboratory.
- Male volunteers must be either vasectomized or agree to use a condom during the course of the study and until 3 months (90 days) after the participant's last visit
- Signing a written informed consent prior to selection
Exclusion Criteria:
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
- Blood donation within 2 months before administration
- General anesthesia within 3 months before administration
- Presence or history of drug hypersensitivity, or allergic disease
- Any drug intake (except paracetamol or contraception) during the 28 days prior to the first administration
- History or presence of alcohol or drug abuse
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Use of an investigational drug within 3 months (or 90 days) prior to Day1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matching placebo
|
Matching placebo
|
Experimental: Part A
Single dose administration
|
Investigational drug
|
Experimental: Part B
Multiple dose administration (food Effect)
|
Investigational drug
|
Experimental: Part C
Multiple dose administration
|
Investigational drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[Part A, Part C] Number of subjects with adverse events (AEs)
Time Frame: Treatment duration up to 4 days
|
The relationship of each adverse event to the investigational product was assessed by the investigator.
|
Treatment duration up to 4 days
|
[Part A, Part C] Safety as assessed by vital signs
Time Frame: Treatment duration up to 4 days
|
Symptoms of vital signs will be assessed.
|
Treatment duration up to 4 days
|
[Part A, Part C] Safety as assessed by abbreviated physical examination parameters
Time Frame: Treatment duration up to 4 days
|
Physical exmaination will include evaluation of main body systems/regions
|
Treatment duration up to 4 days
|
[Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters
Time Frame: Treatment duration up to 4 days
|
12-lead ECGs will be obtained during the study using an ECG machine
|
Treatment duration up to 4 days
|
[Part A, Part C] Safety as assessed by biological analysis
Time Frame: Treatment duration up to 4 days
|
Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.
|
Treatment duration up to 4 days
|
[Part B] Composite of pharmacokinetics (PK) assessments of CKD-510
Time Frame: 3 days post dose
|
PK parameters include plasma concentrations of CKD-510, maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve (AUC) to last measurable concentration [AUC(0-t)], AUC through 24 hours [AUC(0-24)] and AUC per dosing interval [AUC(0-tau)], apparent terminal phase half-life following the last dose (t1/2) in fast or fed conditions.
|
3 days post dose
|
[Part B] Composite of pharmacodynamics (PD) assessments of CKD-510
Time Frame: 3 days post dose
|
Change from baseline in acetylation of alpha-tubulin and histone as pharmacodynamics assessments after an administration of CKD-510 in fast or fed conditions
|
3 days post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[Part A, Part C] Maximum plasma concentration of CKD-510
Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD)
|
Peak plasma concentration (Cmax)
|
4 days post dose (SAD) or 17 days post dose (MAD)
|
[Part A, Part C] Time of maximum plasma concentration of CKD-510
Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD)
|
Time to reach Cmax (Tmax)
|
4 days post dose (SAD) or 17 days post dose (MAD)
|
[Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing
Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD)
|
Area under the concentration-time curve from time 0 extrapolated to the last quantifiable concentration at time t (AUC0-t)
|
4 days post dose (SAD) or 17 days post dose (MAD)
|
[Part A, Part C] Time of plasma elimination half-life of CKD-510
Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD)
|
Apparent terminal elimination half-life (t½)
|
4 days post dose (SAD) or 17 days post dose (MAD)
|
[Part A, Part C] Volume of distribution of CKD-510
Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD)
|
Apparent volume of distribution during the terminal elimination phase (Vd/F)
|
4 days post dose (SAD) or 17 days post dose (MAD)
|
[Part A, Part C] Total plasma clearance of CKD-510
Time Frame: 4 days post dose (SAD) or 17 days post dose (MAD)
|
Apparent total plasma clearance (CL/F)
|
4 days post dose (SAD) or 17 days post dose (MAD)
|
[Part A, Part C] Pharmacodynamics assessments of CKD-510
Time Frame: up to 2 days post dose (SAD) or 17 days post dose (MAD)
|
Change from baseline in acetylation of alpha-tubulin and histone
|
up to 2 days post dose (SAD) or 17 days post dose (MAD)
|
[Part B] Number of subjects with adverse events (AEs)
Time Frame: 3 days post dose
|
The relationship of each adverse event to the investigational product was assessed by the investigator
|
3 days post dose
|
[Part B] Safety as assessed by vital signs
Time Frame: 3 days post dose
|
Symptoms of vital signs will be assessed.
|
3 days post dose
|
[Part B] Safety as assessed by abbreviated physical examination parameters
Time Frame: 3 days post dose
|
Physical exmaination will include evaluation of main body systems/regions
|
3 days post dose
|
[Part B] Safety as assessed by electrocardiogram (ECG) parameters
Time Frame: 3 days post dose
|
12-lead ECGs will be obtained during the study using an ECG machine
|
3 days post dose
|
[Part B] Safety as assessed by biological analysis
Time Frame: 3 days post dose
|
Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.
|
3 days post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 14, 2020
Primary Completion (Actual)
August 24, 2021
Study Completion (Actual)
August 24, 2021
Study Registration Dates
First Submitted
January 15, 2021
First Submitted That Met QC Criteria
February 8, 2021
First Posted (Actual)
February 9, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2022
Last Update Submitted That Met QC Criteria
May 2, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- A96_01CMT1914
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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