Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
D113
CKD-349
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Healthy adult volunteers aged ≥ 19 years
- Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
- Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
- Those who agree to contraception until 7 days after clinical trial.
- Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
- Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
- Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
- Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
- Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
- Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
- Those who are deemed insufficient to participate in this clinical study by investigators.
- Woman who are pregnant or breastfeeding.
Sites / Locations
- H Plus Yangji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1
Sequence2
Arm Description
Period 1: D113/ Period 2: CKD-349
Period 1: CKD-349/ Period 2: D113
Outcomes
Primary Outcome Measures
AUCt of CKD-349
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-349
Cmax: Maximum plasma concentration of the drug
Secondary Outcome Measures
AUCinf of CKD-349
Area under the concentration-time curve from zero up to ∞
Tmax of CKD-349
Time to maximum plasma concentration
AUCt/AUCinf of CKD-349
AUCt/AUCinf
T1/2 of CKD-349
Terminal elimination half-life
Full Information
NCT ID
NCT05089279
First Posted
October 14, 2021
Last Updated
October 5, 2022
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05089279
Brief Title
Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
Official Title
An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
January 18, 2022 (Actual)
Study Completion Date
April 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to Evaluate the Safety and Pharmacokinetics of CKD-349
Detailed Description
An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: D113/ Period 2: CKD-349
Arm Title
Sequence2
Arm Type
Experimental
Arm Description
Period 1: CKD-349/ Period 2: D113
Intervention Type
Drug
Intervention Name(s)
D113
Intervention Description
QD, PO
Intervention Type
Drug
Intervention Name(s)
CKD-349
Intervention Description
QD, PO
Primary Outcome Measure Information:
Title
AUCt of CKD-349
Description
AUCt: Area under the concentration-time curve from time zero to time
Time Frame
0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Title
Cmax of CKD-349
Description
Cmax: Maximum plasma concentration of the drug
Time Frame
0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Secondary Outcome Measure Information:
Title
AUCinf of CKD-349
Description
Area under the concentration-time curve from zero up to ∞
Time Frame
0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Title
Tmax of CKD-349
Description
Time to maximum plasma concentration
Time Frame
0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Title
AUCt/AUCinf of CKD-349
Description
AUCt/AUCinf
Time Frame
0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Title
T1/2 of CKD-349
Description
Terminal elimination half-life
Time Frame
0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult volunteers aged ≥ 19 years
Weight ≥50kg (man) or 45kg (woman), with calculated body mass index (BMI) of 18 to 30 kg/m2
Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.
Those who agree to contraception until 7 days after clinical trial.
Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
Exclusion Criteria:
Those who have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
Those who donated whole blood within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
Those who are deemed insufficient to participate in this clinical study by investigators.
Woman who are pregnant or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JaeWoo Kim
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Plus Yangji Hospital
City
Seoul
State/Province
Gwanak-gu
ZIP/Postal Code
08779
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
We'll reach out to this number within 24 hrs