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

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04768673
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 6
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 24.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes	Drug: CKD-393 formulation I; Drug: CKD-393 formulation II; Drug: D501, D759, H053	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Mar 26, 2021
• Actual Primary Completion Date: Apr 22, 2021
• Actual Study Completion Date: Apr 27, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cmax [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]

   Maximum concentration of drug in plasma

2. AUClast [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]

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

Secondary Outcome Measures

1. 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]

   Area under the plasma drug concentration-time curve from 0 to infinity

2. 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]

   Time to maximum plasma concentration

3. 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]

   Terminal elimination half-life

4. 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]

   Apparent Volume of Distribution

5. 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]

   Apparent Clearance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

[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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul	Seodaemun-gu,	Korea, Republic of	03722

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Min Soo Park, MD, Ph.D, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT04768673
• Other Study ID Numbers: A98_04BE2022P
• First Posted: Feb 24, 2021
• Last Update Posted: Aug 2, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chong Kun Dang Pharmaceutical: CKD-393; Type II Diabetes
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 2, 2021