Clinical trial NCT04334213: A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150
Official title: A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety After Oral Administration of D745, D150 and CKD-501 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 48
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: A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D745 and D150

Detailed description: A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety after Oral Administration of D745, D150 and CKD-501 in Healthy Adults

Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged between 19 and 55-year-old
2. Weight ≥ 55kg (men) or ≥ 50kg (women), with calculated body mass index(BMI) of 18.5 to 27.0 kg/m2
3. Women must meet one of the criteria written below:

   * Menopause (No menstruation for 2 years)
   * Sterilization (Hysterectomy or Oophorectomy, Tubal ligation etc.)
4. Men agree to contraception \& won't donate sperm during the participation of clinical trial
5. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection
2. Those who have clinically significant dehydration or vulnerable to dehydration by poor oral intake
3. Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours before the first administration of investigational product
4. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
5. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug
6. Those who have history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Empagliflozin, Metformin) or additives.
7. Those who have the test results written below

   * AST, ALT \> 1.25 times higher than upper normal level
   * Total bilirubin \> 1.5 times higher than upper normal level
   * eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2
   * "Positive" or "Reactive" test result of Hepatitis B \& C, HIV, RPR
   * Under 5 min resting condition, systolic blood pressure \>150 mmHg or \<90 mmHg, diastolic blood pressure \>100 mmHg or \<50 mmHg
8. Those who have a drug abuse history within one year or positive reaction on urine drug screening test
9. Those who received following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration of the investigational drug Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product
10. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product
11. Those who exceeding an alcohol and smoke consumption criteria or can't stop smoking, consuming alcohol and caffeine during hospitalization period Criteria: Caffeine \> 5 cups/day, Alcohol \> 210 g/week, Smoke \> 10 cigarettes/day
12. Those who took grapefruit before the first administration of investigational product or can't stop taking grapefruit during hospitalization period
13. Those who received investigational product by participating in other clinical trial within 6 months before the first administration of investigational product
14. Those who donated whole blood within 2 months or apheresis within 1 month
15. Those who received transfusion within 1 month
16. Those who are pregnant or breastfeeding
17. Those who are deemed inappropriate to participate in clinical trial by investigators

Primary outcomes:
measure: Cmax,ss of CKD-501, D745, D150
timeFrame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
measure: AUCtau,ss of CKD-501, D745, D150
timeFrame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Secondary outcomes:
measure: Cmin,ss of CKD-501, D745, D150
timeFrame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
measure: Tmax,ss of CKD-501, D745, D150
timeFrame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
measure: CLss/F of CKD-501, D745, D150
timeFrame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
measure: Fluctuation of CKD-501, D745, D150
timeFrame: Day 1, Day 3, Day 4 - Pre-dose (0 hour) / Day 5 - Pre-dose (0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Choon Ok Kim, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: