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

A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-393 and Co-administration of CKD-501, D759 and H053 Under Fed Condition in Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Type II Diabetes
• Intervention / Treatment: Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053

Detailed Description

A randomized, open-label, single-dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety after oral administration of CKD-393 and co-administration of CKD-501, D759 and H053 under fed condition in healthy adults

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu,
    • Seoul, Seodaemun-gu,, Korea, Republic of, 03722
      • Severance Hospital

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. Between 19 aged and 50 aged healthy adult
2. Body weight more than 55kg for male, more than 50kg for female
3. Body Mass Index over 18.5kg/m2 and under 27.0kg/m2

4. 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)

[Exclusion Criteria]

1. 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

2. 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

3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation I / Period 3: CKD-393 Formulation II	Drug: CKD-393 formulation I; single, oral administration of 2 tablets under fed condition; Drug: CKD-393 formulation II; single, oral administration of 2 tablets under fed condition; Drug: D501, D759, H053; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
EXPERIMENTAL: Group 2; Period 1: CKD-393 Formulation I / Period 2: CKD-393 Formulation II / Period 3: CKD-501, D759, H053	Drug: CKD-393 formulation I; single, oral administration of 2 tablets under fed condition; Drug: CKD-393 formulation II; single, oral administration of 2 tablets under fed condition; Drug: D501, D759, H053; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
EXPERIMENTAL: Group 3; Period 1: CKD-393 Formulation II / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation I	Drug: CKD-393 formulation I; single, oral administration of 2 tablets under fed condition; Drug: CKD-393 formulation II; single, oral administration of 2 tablets under fed condition; Drug: D501, D759, H053; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
EXPERIMENTAL: Group 4; Period 1: CKD-501, D759, H053 / Period 2: CKD-393 Formulation II / Period 3: CKD-393 Formulation I	Drug: CKD-393 formulation I; single, oral administration of 2 tablets under fed condition; Drug: CKD-393 formulation II; single, oral administration of 2 tablets under fed condition; Drug: D501, D759, H053; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
EXPERIMENTAL: Group 5; Period 1: CKD-393 Formulation I / Period 2: CKD-501, D759, H053 / Period 3: CKD-393 Formulation II	Drug: CKD-393 formulation I; single, oral administration of 2 tablets under fed condition; Drug: CKD-393 formulation II; single, oral administration of 2 tablets under fed condition; Drug: D501, D759, H053; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
EXPERIMENTAL: Group 6; Period 1: CKD-393 Formulation II / Period 2: CKD-393 Formulation I / Period 3: CKD-501, D759, H053	Drug: CKD-393 formulation I; single, oral administration of 2 tablets under fed condition; Drug: CKD-393 formulation II; single, oral administration of 2 tablets under fed condition; Drug: D501, D759, H053; single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf	Area under the plasma drug concentration-time curve from 0 to infinity	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	Time to maximum plasma concentration	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	Terminal elimination half-life	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	Apparent Volume of Distribution	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	Apparent Clearance	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min Soo Park, MD, Ph.D, Severance Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2021
• Primary Completion (ACTUAL): April 22, 2021
• Study Completion (ACTUAL): April 27, 2021

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Type II Diabetes; CKD-393
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A98_04BE2022P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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