Clinical Trial to Investigate the Pharmacokinetics and Safety After Oral Administration of CKD-378 and Co-administration of D745, D150, D029 in Healthy Adults

NCT05881213 | Completed Phase 1

• 1 other identifier: A129_02BE2227
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical trial to compare and evaluate the safety and pharmacokinetics of CKD-378

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (2)

• area under the curve (AUC)t of CKD-378

  Area under the concentration-time curve time zero to time

  Pre-dose(0 hour) to 48 hours

• Cmax of CKD-378

  Maximum plasma concentration of the drug

  Pre-dose(0 hour) to 48 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

* Period 1: D745, D150, D029 - A single oral dose of 3tablets under food intake condition * Period 2: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition

Drug: CKD-378 (low-dose)

Sequence 2

EXPERIMENTAL

* Period 1: CKD-378 (low-dose) - A single oral dose of 1tablet under food intake condition * Period 2: D745, D150, D029 - A single oral dose of 3tablets under food intake condition

Drug: CKD-378 (low-dose)

Interventions

CKD-378 (low-dose) DRUG

Quaque day (QD), PO

Sequence 1; Sequence 2

Eligibility Criteria

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

You may qualify if:

• Healthy adults aged between 19 and 55 years at screening.
• Those whose body weight 55 kg or over for men and 50 kg or over for women.
• Those with body mass index (BMI) was more than 18.5 kg/m2 and less than 27.0 kg/m2.
• ※ BMI (kg/m2) = body weight (kg)/ \[height (m)\]2
• If women, those who met any one of the following criteria.
• Menopause (no natural menstruation for at least 2 years)
• Surgical infertility (hysterectomy or bilateral oophorectomy, tubal ligation, or infertility by other methods)
• Male subjects with female sexual partners of childbearing potential must agree to use methods of birth control (using condom) and not donate sperm during the study and for up to 28 days after the last administration of the IP (unless the male subjects or their female partners are infertile).
• Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting a detailed explanation and full understanding of the study.

You may not qualify if:

• Subjects with history or current conditions of clinically significant disease, including hepatobiliary (e.g., severe hepatic dysfunction, etc.), renal (e.g., severe renal insufficiency, etc.), nervous, immune, respiratory (e.g., bronchial asthma) urinary, gastrointestinal, endocrine (e.g., patients with diabetic ketoacidosis, diabetic coma and pre-coma, and type 1 diabetes mellitus, etc.), hemato-oncology, or cardiovascular (e.g., heart failure, etc.) or psychiatric disorders.
• Subjects who are susceptible to dehydration due to inadequate oral intake or who have clinically significant dehydration.
• Subjects who underwent a test using intravenous administration of radioiodine contrast media (e.g., intravenous urography, venous cholangiography, angiography, or computed tomography using a contrast medium) within 48 hours prior to the first IP administration.
• Subjects with a history or current conditions of serious urinary tract infection.
• Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• Subjects with a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, etc.) or surgery (except simple appendectomy or hernia surgery) that may affect the absorption of IP.
• Subjects with a history of clinically significant hypersensitivity to drugs, including components of the IPs (empagliflozin or metformin) or additives.
• Subjects who were deemed unfit for participation in this study based on the following findings in the screening tests performed within 28 days before the first IP administration.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \> 1.25 times the upper limit of normal range.
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 when calculated with the modification of diet in renal disease (MDRD) formula.
• Positive result for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or syphilis infection test.
• Systolic blood pressure \> 150 mmHg or \<90 mmHg, or diastolic blood pressure \> 100 mmHg or \<50 mmHg which is measured in sitting position after resting for more than 5 minutes.
• Subjects with a history of drug abuse within a year prior to screening or positive results in urine drug screening tests.
• Women who are pregnant or breast-feeding.
• Subjects who took the following drugs, excluding the topical agents without significant systemic absorption, within the predefined period the investigator judges they could affect the results of the study or compromise the safety of the subject.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, 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 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: May 18, 2023
• First Posted: May 31, 2023
• Study Start: June 1, 2023
• Primary Completion: June 28, 2023
• Study Completion: July 10, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)