A Clinical Trial to Evaluate the Food Effect of CKD-378

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Food Effect on the Pharmacokinetics and Safety of CKD-378 in Healthy Volunteers

A clinical trial to evaluate the food effect of CKD-378

Study Overview

• Status: Completed
• Conditions: Type II Diabetes Mellitus
• Intervention / Treatment: Drug: CKD-378, QD, PO

Detailed Description

An open-label, randomized, single-dose, 2-sequence, 2-period, crossover, phase 1 study to evaluate the food effect on the pharmacokinetics and safety of CKD-378 in healthy volunteers

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Gimpo-si, Gyeonggi-do, Korea, Republic of, 10099
      • Gimpo Woori Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adult aged ≥ 19 at screening
2. Body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0kg/m2 and Body weight ≥ 50kg
3. Those who do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
4. A person who is deemed suitable as a subject as a result of screening such as clinical laboratory examination (hematology, blood chemistry, serological tests, urinalysis, etc.), electrocardiogram examination, etc.
5. A person who has received a sufficient explanation of the purpose and contents of the clinical trial and has agreed in writing voluntarily to participate in the clinical trial
6. A person who has agreed to use appropriate contraception and not donate sperm or eggs until 1 week after the first administration of the drug and the last administration of the drug

Exclusion Criteria:

1. Those who have taken a drug known to significantly induce or inhibit drug metabolizing enzymes within 30 days before the first administration of investigational product, or who have taken drug that may interfere with this investigational product within 10 days

2. Those with a history of regular alcohol intake before the first administration of investigational product

   • More than 21 drinks/week for men
   • More than 14 drinks/week for women
3. Those who have taken other investigational product within 6 months before the first administration of the investigational product
4. Those who have donated whole blood within 8 weeks or donated component blood within 2 weeks or received blood transfusion within 4 weeks before the first administration of the investigational product
5. Those with a history of gastrointestinal diseases or surgery (except simple appendicectomy, hernia surgery) that may affect drug absorption ruler

6. Those who have following diseases

   • Patients with hypersensitivity to the ingredient of an investigational drug or to biguanide drugs
   • Patients with moderate and severe renal impairment, end-stage renal disease or dialysis
   • Patients with acute conditions that may affect renal function
   • Patients with acute or chronic metabolic acidosis and patients with a history of ketoacidosis
   • Diabetic precoma patient
   • Patients with acute and unstable heart failure
   • Patients receiving tests using intravenous radioactive iodine contrast material
   • Patients with severe infections or severe traumatic systemic disorders
   • Patients scheduled for surgery
   • Patients with malnutrition, starvation, weakness, pituitary dysfunction, or adrenal dysfunction
   • Patients with gastrointestinal disorders
7. A history of clinically significant psychiatric disease
8. Those who are judged by the investigator for reason other than the above selection/exclusion criteria and are judged unsuitable for participation in the study
9. Woman who are suspected of being pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: A single oral dose of 2 tablets(CKD-378) under fasting condition; Period 2: A single oral dose of 2 tablets(CKD-378) under fed condition	Drug: CKD-378, QD, PO; CKD-378, QD, PO
Experimental: Sequence 2; Period 1: A single oral dose of 2 tablets(CKD-378) under fed condition; Period 2: A single oral dose of 2 tablets(CKD-378) under fasting condition	Drug: CKD-378, QD, PO; CKD-378, QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-378	Area under the concentration-time curve time zero to time	Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours
Cmax of CKD-378	Maximum plasma concentration of the drug	Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: A129_03FDI2317

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