Clinical trial NCT04221360: A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375
Official title: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cmax of D390 and CKD-375
timeFrame: 0(predose)~48 hours
measure: AUClast of D390 and CKD-375
timeFrame: 0(predose)~48 hours
Secondary outcomes:
measure: AUCinf of D390 and CKD-375
timeFrame: 0(predose)~48 hours
measure: Tmax of D390 and CKD-375
timeFrame: 0(predose)~48 hours
measure: t1/2 of D390 and CKD-375
timeFrame: 0(predose)~48 hours
measure: Vd/F of D390 and CKD-375
timeFrame: 0(predose)~48 hours
measure: CL/F of D390 and CKD-375
timeFrame: 0(predose)~48 hours
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: