Clinical trial NCT06386328: A Clinical Trial to Evaluate the Food Effect of CKD-378
Official title: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type II Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: AUCt of CKD-378
timeFrame: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours
measure: Cmax of CKD-378
timeFrame: Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24, 32, 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gimpo-si
country: Korea, Republic of
facility: Gimpo Woori hospital
state: Gyeonggi-do
Study officials:
References: