A Study to Investigate the PK and Safety of CKD-393

NCT04768673 | Completed Phase 1

• 1 other identifier: A98_04BE2022P
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393

Conditions

Type II Diabetes

Keywords

CKD-393; Type II Diabetes

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum concentration of drug in plasma

  0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

• AUClast

  Area under the plasma drug concentration-time curve to last concentration

  0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

Secondary Outcomes (5)

• AUCinf

  0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

• Tmax

  0 h (hours)h, 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

• t1/2

  0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

• Vd/F

  0 h (hours), 0.25 h (hours)h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

• CL/F

  0 h (hours), 0.25 h (hours), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 24h, 32h, 48h

Study Arms (6)

Group 1

EXPERIMENTAL

Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation I / Period 3: CKD-393 Formulation II

Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Group 2

EXPERIMENTAL

Period 1: CKD-393 Formulation I / Period 2: CKD-393 Formulation II / Period 3: CKD-501, D759, H053

Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Group 3

EXPERIMENTAL

Period 1: CKD-393 Formulation II / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation I

Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Group 4

EXPERIMENTAL

Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation II / Period 3: CKD-393 Formulation I

Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Group 5

EXPERIMENTAL

Period 1: CKD-393 Formulation I / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation II

Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Group 6

EXPERIMENTAL

Period 1: CKD-393 Formulation II / Period 2: CKD-393 Formulation I / Period 3: CKD-501, D759, H053

Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Interventions

CKD-393 formulation I DRUG

single, oral administration of 2 tablets under fed condition

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

CKD-393 formulation II DRUG

single, oral administration of 2 tablets under fed condition

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

D501, D759, H053 DRUG

single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

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

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 19 aged and 50 aged healthy adult
• Body weight more than 55kg for male, more than 50kg for female
• Body Mass Index over 18.5kg/m2 and under 27.0kg/m2
• if female, the subject must satisfy more than one of the following:
• subject who have reached menopause (no natural menstruation for at least 2 years.)
• subject who is surgically infertile(hysterectomy or bilateral salpingo-oophorectomy, tubal ligation, or in infertile state under other method)

You may not qualify if:

• Subject who is currently with or have diagnosed with clinically significant hepatobiliary(severe hepatopathy, etc.), kidney(severe nephropathy, etc.), neurological, immunologic, respiratory, urinary, gastrointestinal endocrinological(diabetic ketoacidosis, diabetic coma, etc.), hematological, oncological, cardiovascular(heart failure, etc.) or metal illness
• Subject with one of the following laboratory test results
• AST, ALT \> UNLx1.5
• eGRF \< 60 ml/min/1.73 m2 (MDRD formula)
• immuno-serology test results in positive
• Systolic blood pressure \> 150mmHg or \<90mmHg, Diastolic blood pressure \>100mmHg or \<50mmHg
• Subject who has history of the following and the history may affect safety of the subject or result of this study
• History of any prescription drug or herbal medicine within 14 days before first administration investigational products
• History of any non-prescription drug including health food, vitamin within 7 days before first administration investigational products
• History of drug-metabolizing induction/inhibition enzyme such as barbital

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu,, 03722, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Min Soo Park, MD, Ph.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

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 22, 2021
• First Posted: February 24, 2021
• Study Start: March 26, 2021
• Primary Completion: April 22, 2021
• Study Completion: April 27, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)