A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D759 and D150 (CKD-393)

A Randomized, Open-label, 2-Part, Multiple-dose, Two-way Crossover Clinical Trial to Evaluate Drug-drug Interactions and Safety Between CKD-501, D759, and D150 in Healthy Adults

A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D759 and D150

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CKD 501; Drug: CKD-501, D759, D150; Drug: D759, D150

Detailed Description

A Randomized, Open-label, 2-Part, Multiple-dose, Two-way Crossover Clinical Trial to Evaluate Drug-drug Interactions and safety between CKD-501, D759, and D150 in Healthy Adult

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

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang
    • Seongnam-si, Bundang, Korea, Republic of, 13497
      • CHA Bundang Medical Center, CHA University

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. 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
2. Healthy adult volunteers aged between 19 and 55-year-old
3. Weight ≥ 50kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 18.0 to 30.0 kg/m2

Exclusion Criteria:

1. Those who have history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Sitagliptin, Metformin) or additives.
2. 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
3. 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
4. Those who have Drug abuse (especially sleeping drugs, central analgesics, opiates or psychotropic drugs such as psychotropic drugs) or persons with a history of substance abuse

5. 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
6. Those who have determined that the abnormal results are clinically significant in the screening test items (question, vital signs, electrocardiogram, physical test, blood, urine test, etc.)
7. Those who have participated in other clinical trials within 180 days of the intended study drug administration and have been administered clinical trial medications (except for those who have not taken the study medication)
8. Those who has taken a drug (specialized drug, generic drug, herbal medicine, or nutritional supplement (vitamin, etc.)) within 2 weeks prior to screening (however, if it is considered that it does not affect the safety and research results of the subject, as determined by the investigator) You can participate in the test.)
9. Those who donated whole blood within 8 weeks prior to screening, or who donated or donated components (plasma, platelets) within 4 weeks, and consented to prohibit blood donation from 30 days after the last dose Not.
10. Those who have continuously consumed more than 21 units/week (1 unit of alcohol = 10 g = 12.5 mL) within 6 months prior to screening
11. Those who have More than 10 smokers a day within 6 months prior to screening
12. Those who cannot use clinically acceptable contraceptive methods (e.g., infertility surgery between themselves and partners, intrauterine contraceptive devices, use of diaphragms or condoms) from the time the drug is administered to the last visit
13. Those who cannot inhibit the diet (especially grapefruit juice, caffeine) that can affect the absorption, distribution, metabolism, and excretion of the drug from 3 days before the last administration of the investigational drug to the last visit.
14. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
15. 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
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
• Masking: NONE

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, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).	Drug: CKD 501; QD, PO; Other Names: CKD-501; Drug: CKD-501, D759, D150; QD, PO
EXPERIMENTAL: Sequence 2; Period 1: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 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; Other Names: CKD-501; Drug: CKD-501, D759, D150; QD, PO
EXPERIMENTAL: Sequence 3; Period 1: D759, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D759: 1 tablet, D150: 2 tablets). Period 2: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).	Drug: CKD-501, D759, D150; QD, PO; Drug: D759, D150; QD, PO
EXPERIMENTAL: Sequence 4; Period 1: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets). Period 2: D759, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D759: 1 tablet, D150: 2 tablets).	Drug: CKD-501, D759, D150; QD, PO; Drug: D759, D150; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax,ss of CKD-501, D759, D150	Cmax,ss: Maximum concentration of drug in plasma at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
AUCtau,ss of CKD-501, D759, D150	AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmin,ss of CKD-501, D759, D150	Cmin,ss: Minimum concentration of drug in plasma at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Tmax,ss of CKD-501, D759, D150	Tmax,ss: Time to maximum plasma concentration at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
t1/2,ss of CKD-501, D759, D150	t1/2,ss: Terminal half-life at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
CLss/F of CKD-501, D759, D150	CLss/F: Apparent Clearance at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Fluctuation of CKD-501, D759, D150	Fluctuation: Peak trough fluctuation within one dosing interval	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Vd,ss/F of CKD-501, D759, D150	Vd,ss/F: Apparent Volume of distribution at steady state	CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2020
• Primary Completion (ACTUAL): July 24, 2020
• Study Completion (ACTUAL): October 26, 2020

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: June 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: A98_02DDI2004

Drug and device information, study documents

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