Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393
Primary Purpose
T2DM (Type 2 Diabetes Mellitus)
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-501, D759, D150
CKD-393 0.5/100/1000 mg
Sponsored by
About this trial
This is an interventional treatment trial for T2DM (Type 2 Diabetes Mellitus)
Eligibility Criteria
Inclusion Criteria:
- Healthy adult who is 19 ~ 55 years at the time of screening
- Body weight more than 55 kg for male and more than 50kg for female
- BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
- Females must be menopause or surgical infertility
- Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
- Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.
Exclusion Criteria:
- Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
- Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Subjects with poor oral intake, susceptible to dehydration or clinically significant dehydration
- Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
- Subjects who have a history of clinically significant hypersensitivity to drugs or additives
- Subjects who have severe infectious disease and severe trauma before and after operation
- Subjects who have undergone i.v. testing of radioactive iodine contrast material within 48 hours before the first IP administration
Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
- AST, ALT> UNL(Upper Normal Limit)x1.25
- eGFR (Estimated Glomerular Filtration Rate) <60 mL/min/1.73m2 using the MDRD (Modification of Diet in Renal Disease) equation
- Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
- After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg
- Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons
- Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug.
- Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
- Inducing or inhibiting drugs of drug-metabolism enzyme, within 30 days of the first dose of the investigational product
- Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
- Subjects who take grapefruit-containing food within 7 days before IP administration, or cannot forbid taking grapefruit-containing food for period of clinical trials.
- Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
- Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
- Subjects who received a blood transfusion within 30 days before the first dose of the investigational product
- Pregnant or lactating women
- Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Period 1: Treatment A Period 2: Treatment B
Period 1: Treatment B Period 2: Treatment A
Outcomes
Primary Outcome Measures
AUCt(Area Under Curve last) of CKD-393
Area under the plasma concentration time curve of CKD-393, from time zero up to the last measurable concentration.
Cmax of CKD-393
The maximum concentration observed of CKD-393 over blood sampling time.
Secondary Outcome Measures
Full Information
NCT ID
NCT04706286
First Posted
January 10, 2021
Last Updated
January 10, 2021
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT04706286
Brief Title
Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393
Official Title
A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393 and Co-administration of CKD-501, D759 and D150 Under Fed Condition in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 18, 2021 (Anticipated)
Primary Completion Date
March 29, 2021 (Anticipated)
Study Completion Date
April 5, 2021 (Anticipated)
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
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-393 0.5/100/1000 mg under fed condition
Detailed Description
A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-393 0.5/100/1000 mg under fed condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T2DM (Type 2 Diabetes Mellitus)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Period 1: Treatment A
Period 2: Treatment B
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Period 1: Treatment B
Period 2: Treatment A
Intervention Type
Drug
Intervention Name(s)
CKD-501, D759, D150
Other Intervention Name(s)
Treatment A
Intervention Description
CKD-501 0.5 mg 1T, D759 100 mg 1T and D150 1000 mg 1T, single oral administration under fed condition
Intervention Type
Drug
Intervention Name(s)
CKD-393 0.5/100/1000 mg
Other Intervention Name(s)
Treatment B
Intervention Description
CKD-393 0.5/100/1000 mg 1T, single oral administration under fed condition
Primary Outcome Measure Information:
Title
AUCt(Area Under Curve last) of CKD-393
Description
Area under the plasma concentration time curve of CKD-393, from time zero up to the last measurable concentration.
Time Frame
From predose, upto 48 hours post-dose
Title
Cmax of CKD-393
Description
The maximum concentration observed of CKD-393 over blood sampling time.
Time Frame
From predose, upto 48 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult who is 19 ~ 55 years at the time of screening
Body weight more than 55 kg for male and more than 50kg for female
BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
Females must be menopause or surgical infertility
Males who have consented to the use of appropriate pregnancy contraceptive methods up to 28 days after the last investigational product and not to provide sperm
Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.
Exclusion Criteria:
Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hematooncology, cardiovascular systemic disease or psychosis disorder
Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subjects with poor oral intake, susceptible to dehydration or clinically significant dehydration
Subjects who have a history of gastrointestinal disorders (Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the drug
Subjects who have a history of clinically significant hypersensitivity to drugs or additives
Subjects who have severe infectious disease and severe trauma before and after operation
Subjects who have undergone i.v. testing of radioactive iodine contrast material within 48 hours before the first IP administration
Subjects who are deemed unsuitable as subjects in the screening test performed within 28 days before the administration of investigational product
AST, ALT> UNL(Upper Normal Limit)x1.25
eGFR (Estimated Glomerular Filtration Rate) <60 mL/min/1.73m2 using the MDRD (Modification of Diet in Renal Disease) equation
Positive immunologic serological tests (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test)
After resting for more than 5 minutes, systolic blood pressure> 150 mmHg or < 90 mmHg, diastolic blood pressure> 100 mmHg or <50 mmHg
Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
Subjects who judged to able to affect in the study or in the subject's safety by the investigator for the following reasons
Ethical-the-counter (ETC) drugs and herbal medicines within 14 days of the first administration of the investigational drug.
Over-the-counter (OTC) drugs, including health foods and vitamin preparations, within 7 days of the first dose of the investigational product
Inducing or inhibiting drugs of drug-metabolism enzyme, within 30 days of the first dose of the investigational product
Subjects who have consistently excessively smoked or consumed caffeine or alcohol (caffeine:> 5 cups / day, alcohol:> 210 g / week, cigarettes:> 10 cigarettes / day) or cannot stop smoking, consuming caffeine and alcohol during hospitalization
Subjects who take grapefruit-containing food within 7 days before IP administration, or cannot forbid taking grapefruit-containing food for period of clinical trials.
Subjects who have received the investigational product by participating in other clinical trials (including bioequivalence studies) within 180 days before the first dose of the investigational product (For biological agents, this may be based on a longer period of time, considering the half-life)
Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
Subjects who received a blood transfusion within 30 days before the first dose of the investigational product
Pregnant or lactating women
Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choon Ok Kim, M.D., Ph.D.
Phone
+82-2-2228-0455
Email
DELIVERY98@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choon Ok Kim, M.D., Ph.D.
Organizational Affiliation
Severance hospital of the Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393
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