Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects

NCT ID: NCT04260438

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2020-06-24

Brief Summary

This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects

Detailed Description

To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.

Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

1. Period 1: Treatment A

2. Period 2: Treatment B

3. Period 3: Treatment C

Group Type: EXPERIMENTAL

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

Group 2

1. Period 1: Treatment A

2. Period 2: Treatment C

3. Period 3: Treatment B

Group Type: EXPERIMENTAL

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

Group 3

1. Period 1: Treatment B

2. Period 2: Treatment A

3. Period 3: Treatment C

Group Type: EXPERIMENTAL

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

Group 4

1. Period 1: Treatment B

2. Period 2: Treatment C

3. Period 3: Treatment A

Group Type: EXPERIMENTAL

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

Group 5

1. Period 1: Treatment C

2. Period 2: Treatment A

3. Period 3: Treatment B

Group Type: EXPERIMENTAL

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

Group 6

1. Period 1: Treatment C

2. Period 2: Treatment B

3. Period 3: Treatment A

Group Type: EXPERIMENTAL

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Intervention Type: DRUG

single oral administration under fed condition

Interventions

CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T

single oral administration under fed condition

Intervention Type: DRUG

CKD-393 0.5/100/1000mg formulation 1 Tab. 1T

single oral administration under fed condition

Intervention Type: DRUG

CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

single oral administration under fed condition

Intervention Type: DRUG

Other Intervention Names

Treatment A; Treatment B; Treatment C

Eligibility Criteria

Inclusion Criteria

1. Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.

2. Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2

• BMI = Weight(kg)/ Height(m)2

3. Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.

4. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.

Exclusion Criteria

1. History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.

2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.

3. Any medical history that may affect drug absorption, distribution, metabolism and excretion.

4. Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse

• Thiazolidinedione
• DPP-4 inhibitor
• Metformin

5. Any clinically significant chronic medical illness.

6. Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

7. Individuals with one of the following laboratory test results in screening

• AST, ALT > UNL (upper normal limit) x 3
• fasting glucose < 70 mg/dL or > 125 mg/dL
• Creatinine clearance ≤ 80 mL/min
• In ECG result, QTc > 450 msec
• hCG(+) (only women)

8. Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.

9. Use of any prescription drugs within 14 days prior to study drug administration.

10. Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.

11. History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).

12. Individuals who cannot eat standard meal provided from clinical trial center.

13. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.

14. Individuals who had received a blood transfusion within 30 days prior to study drug administration.

15. Exposure to any investigational drug within 6 months prior to the first IP administration.

16. Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.

17. Individuals who had consumed grapefruit juice > 5cups/day or caffeine > 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.

18. Individuals who had drinking (alcohol > 30 g/day) within 30 days prior to the first IP administration or who cannot stopping drink.

19. Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.

20. Pregnant or women who may be pregnant

21. Subjects having been deemed inappropriate for the trial as determined by the investigator.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Korea University Anam Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A98_01BE1922P

Identifier Type: -

Identifier Source: org_study_id