A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150

Type 2 Diabetes Clinical Trial

— CKD-383  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334213
• Other study ID #: A101_01DDI1927
• Status: Completed
• Phase: Phase 1
• Start date: May 7, 2020
• Est. completion date: August 5, 2020

Study information

• Verified date: March 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D745 and D150

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• CKD-501
QD, PO
• D745, D150
QD, PO
• CKD-501, D745, D150
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss of CKD-501, D745, D150	Cmax,ss: Maximum concentration of drug in plasma at steady state	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
Primary	AUCtau,ss of CKD-501, D745, D150	AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(t) at steady state	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	Cmin,ss of CKD-501, D745, D150	Cmin,ss: Minimum concentration of drug in plasma at steady state	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	Tmax,ss of CKD-501, D745, D150	Tmax,ss: Time to maximum plasma concentration at steady state	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	CLss/F of CKD-501, D745, D150	CLss/F: Apparent Clearance at steady state	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	Fluctuation of CKD-501, D745, D150	Fluctuation: Peak trough fluctuation within one dosing interval	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