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

NCT04260438 | Completed Phase 1

• 1 other identifier: A98_01BE1922P
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• AUCt of CKD-501, D759, D150, CKD-393

  Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final

  Time Frame: 0 hour ~ 48 hours

• Cmax of CKD-501, D759, D150, CKD-393

  The maximum CKD-501/D759/D150/CKD-393 concentration in blood sampling time t

  Time Frame: 0 hour ~ 48 hours

Study Arms (6)

Group 1

EXPERIMENTAL

1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C

Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Group 2

EXPERIMENTAL

1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B

Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Group 3

EXPERIMENTAL

1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C

Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Group 4

EXPERIMENTAL

1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A

Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Group 5

EXPERIMENTAL

1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B

Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Group 6

EXPERIMENTAL

1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A

Drug: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T; Drug: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T

Interventions

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

single oral administration under fed condition

Also known as: Treatment A

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

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

single oral administration under fed condition

Also known as: Treatment B

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

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

single oral administration under fed condition

Also known as: Treatment C

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.
• Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
• \* BMI = Weight(kg)/ Height(m)2
• Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
• 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.

You may not qualify if:

• History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.
• With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
• Any medical history that may affect drug absorption, distribution, metabolism and excretion.
• 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
• Any clinically significant chronic medical illness.
• Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• 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)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: April 8, 2020
• Primary Completion: June 15, 2020
• Study Completion: June 24, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)