Clinical trial NCT04651881: Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cardiovascular Diseases
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 24
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: Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under fed conditions

Detailed description: A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fed conditions

Eligibility criteria: Inclusion Criteria:

1. Healthy adult aged more than 19 at the time of screening
2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) \< 30.0kg/m²

   # BMI=Weight(kg) / Height(m)²
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
6. Those who agree to double contraception method from the 1st dministration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, mpacted teeth, wisdom teeth).
2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
6. Those who have taken any drugs that may affect the clinical trial within 10 days.
7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
8. Those who is unable to consume a high-fat meal provided during the study.
9. Those who are deemed insufficient to participate in this clinical study by investigators.

Primary outcomes:
measure: AUCt of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
measure: Cmax of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Secondary outcomes:
measure: AUCinf of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
measure: Tmax of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
measure: T1/2 of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
measure: CL/F of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
measure: Vd/F of CKD-385
timeFrame: Pre-dose (0 h),1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48 hours
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Central Hospital
state: Siheung-si
Study officials:
affiliation: CENTRAL HOSPITAL
name: Min-gi Kim
role: PRINCIPAL_INVESTIGATOR
References: