A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150 (CKD-383)

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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: CKD-501; Drug: CKD-501, D745, D150; Drug: D745, 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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days. Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).	Drug: CKD-501; QD, PO; Drug: CKD-501, D745, D150; QD, PO
Experimental: Sequence 2; Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days	Drug: CKD-501; QD, PO; Drug: CKD-501, D745, D150; QD, PO
Experimental: Sequence 3; Period 1: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets). Period 2: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets).	Drug: CKD-501, D745, D150; QD, PO; Drug: D745, D150; QD, PO
Experimental: Sequence 4; Period 1: CKD-501, D745, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D745: 1 tablet, D150: 2 tablets). Period 2: D745, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D745: 1 tablet, D150: 2 tablets).	Drug: CKD-501, D745, D150; QD, PO; Drug: D745, D150; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AUCtau,ss of CKD-501, D745, D150	AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Choon Ok Kim, M.D., PhD., Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): August 5, 2020
• Study Completion (Actual): August 5, 2020

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: A101_01DDI1927

Drug and device information, study documents

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