A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-375.

Study Overview

• Status: Unknown
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-375; Drug: D390

Detailed Description

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of High Dose CKD-375 and D390 in Healthy Adults.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min Soo Park, M.D., Ph.D.; Phone Number: +82-2-2228-0401; Email: minspark@yuhs.ac

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult who is 19 ~ 55 years at the time of screening
2. Body weight more than 55 kg for male and more than 50kg for female
3. BMI more than 18.5 kg/m2 or less than 27.0 kg/m2
4. Females must be menopause or surgical infertility
5. 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
6. Subjects who voluntarily decided to participate and informed consent based upon understanding on the study.

Exclusion Criteria:

1. Subjects who have a history of clinically significant hepatic, renal, nervous, immune, respiratory, urinary, digestion, endocrine, hemato-oncology, cardiovascular systemic disease or psychosis disorder
2. Subjects who has clinically significant dehydration or is vulnerable to dehydration due to poor oral intake
3. Subjects who underwent intravenous administration of radioactive iodine contrast agents (e.g., intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours prior to the first dose of the investigational product
4. Subjects who have a significant urinary tract infection or have such a history
5. Subjects who have genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
6. 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
7. Subjects who have a history of clinically significant hypersensitivity to drugs or additives, including components of the investigational product (empagliflozin, metformin)

8. 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
   • Total bilirubin > UNL(Upper Normal Limit)x1.5
   • eGFR (Estimated Glomerular Filtration Rate) <60 mL / min / 1.73m2 using the MDRD (Modification of Diet in Renal Disease) formula
   • 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
9. Subjects who have had a history of drug abuse within one year of screening or have tested positive on urine drug screening test
10. Pregnant or lactating women
11. 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

12. Subjects who took any of the following drugs except for topical without serious systemic absorption and hormonal contraceptives and are deemed that the administered drug may affect in the study or the safety of the subject by the investigator

    • 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
    • Drugs administered by depot injection or through iomplantation in the human body within 30 days of the first dose of investigational product
13. 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)
14. Subjects who donated whole blood within 60 days before the first dose of the investigational product or donated component blood donation within 30 days
15. Subjects who were deemed to be inappropriate to participate in the study by the investigator judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Period 1: D390; Period 2: CKD-375	Drug: CKD-375; Test drug, QD, PO; Drug: D390; Reference drug, QD, PO
Experimental: Group 2; Period 1: CKD-375; Period 2: D390	Drug: CKD-375; Test drug, QD, PO; Drug: D390; Reference drug, QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of D390 and CKD-375	Maximum plasma concentration of D390 and CKD-375	0(predose)~48 hours
AUClast of D390 and CKD-375	Area under the plasma concentration-time curve to last concentration of D390 and CKD-375	0(predose)~48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of D390 and CKD-375	Area under the plasma concentration-time curve from zero to infinity concentration of D390 and CKD-375	0(predose)~48 hours
Tmax of D390 and CKD-375	Time to maximum plasma concentration of D390 and CKD-375	0(predose)~48 hours
t1/2 of D390 and CKD-375	Half-life of D390 and CKD-375	0(predose)~48 hours
Vd/F of D390 and CKD-375	Apparent volume of distribution of D390 and CKD-375	0(predose)~48 hours
CL/F of D390 and CKD-375	Apparent clearance of D390 and CKD-375	0(predose)~48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min Soo Park, M.D., Ph.D., Severance Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 29, 2020
• Primary Completion (Anticipated): March 6, 2020
• Study Completion (Anticipated): June 8, 2020

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A92_02BE1920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No