Pharmacokinetics and Safety/Tolerability Profile of CKD-379

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05452525
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 2.2
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

A study to compare the pharmacokinetics and safety/tolerability between CKD-379 tablet and D759, D745, D150 combination

Condition or Disease	Intervention/Treatment	Phase
Type II Diabetes Mellitus	Drug: CKD-379 I; Drug: CKD-379 II; Drug: D759+D745+D150	Phase 1

Detailed Description

A randomized, open-label, single dose, 3-period, 6-treatment, crossover study to compare the pharmacokinetics and safety/tolerability of CKD-379 in healthy subjects under fed conditions

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Single Dose, 3-period, 6-treatment, Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of CKD-379 and Coadministration of D759, D745 and D150 in Healthy Subjects
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Aug 25, 2022
• Anticipated Study Completion Date: Sep 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: Test drug(CKD-379 I) Period 2: Test drug(CKD-379 II) Period 3: Reference drug(D759+D745+D150)	Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition; Drug: D759+D745+D150; 3 tablet coadministration under fed condition
Experimental: Sequence 2 Period 1: Test drug(CKD-379 I) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 II)	Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition; Drug: D759+D745+D150; 3 tablet coadministration under fed condition
Experimental: Sequence 3 Period 1: Test drug(CKD-379 II) Period 2: Reference drug(D759+D745+D150) Period 3: Test drug(CKD-379 I)	Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition; Drug: D759+D745+D150; 3 tablet coadministration under fed condition
Experimental: Sequence 4 Period 1: Test drug(CKD-379 II) Period 2: Test drug(CKD-379 I) Period 3: Reference drug(D759+D745+D150)	Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition; Drug: D759+D745+D150; 3 tablet coadministration under fed condition
Experimental: Sequence 5 Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 I) Period 3: Test drug(CKD-379 II)	Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition; Drug: D759+D745+D150; 3 tablet coadministration under fed condition
Experimental: Sequence 6 Period 1: Reference drug(D759+D745+D150) Period 2: Test drug(CKD-379 II) Period 3: Test drug(CKD-379 I)	Drug: CKD-379 I; 1 tablet administration under fed condition; Drug: CKD-379 II; 1 tablet administration under fed condition; Drug: D759+D745+D150; 3 tablet coadministration under fed condition

Outcome Measures

Primary Outcome Measures

1. Cmax [0~48hours]

   Maximum plasma concentration of the drug

2. AUClast [0~48hours]

   Area under the concentration-time curve from the time of dosing to the last measurable concentration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Between 19 aged and 50 aged in healthy adult

• 50.0kg ≤ Body weight ≤ 90.0kg and 18.0kg/m2 ≤ body mass index (BMI) ≤ 27.0kg/m2

Exclusion Criteria:

• Have clinical significant medical history or disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, digestive system, urinary system, endocrine system(Type I or Type II Diabetes Mellitus, diabetic ketoacidosis ect.), hematological system, cardiovascular system(heart failure, Torsades de pointes etc.), mental illness

• Have clinical significant medical history or disease that urinary tract infection or genital infection including urosepsis, pyelonephritis

• Have a gastrointestinal disease(Crohn's disease, ulcer ect.) history that can effect drug absorption or surgery

• Those who are pregnant or breastfeeding

• Those who are deemed inappropriate to participate in clinical trial by investigators

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of	03080

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Jaeseong Oh, M.D., Ph.D., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05452525
• Other Study ID Numbers: A125_01BE2204
• First Posted: Jul 11, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• 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
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 11, 2022