Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

[Part A, Part C] Number of subjects with adverse events (AEs)
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
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
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
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
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
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
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 Outcomes (12)

[Part A, Part C] Maximum plasma concentration of CKD-510
4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Time of maximum plasma concentration of CKD-510
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
4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Time of plasma elimination half-life of CKD-510
4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Volume of distribution of CKD-510
4 days post dose (SAD) or 17 days post dose (MAD)
+7 more secondary outcomes

Study Arms (4)

Part A

EXPERIMENTAL

Single dose administration

Drug: CKD-510 single dose

Part B

EXPERIMENTAL

Multiple dose administration (food Effect)

Drug: CKD-510 food effect

Part C

EXPERIMENTAL

Multiple dose administration

Drug: CKD-510 multiple dose

Interventions

CKD-510 single doseDrug

Investigational drug

Part A

CKD-510 food effectDrug

Investigational drug

Part B

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male subject
Non-smoker subject or light smoker

Sponsors & Collaborators

Chong Kun Dang Pharmaceutical
Industrylead

Study Sites (1)

Clinical site

Grenoble, France

Enrollment

87 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

January 15, 2021

First Posted

February 9, 2021

Study Start

January 14, 2020

Actual (reported)

Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (12)

Study Arms (4)

Part A

Part B

Part C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (12)

Study Arms (4)

Part A

Part B

Part C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations