Clinical trial NCT04906785: 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 Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 High-dose 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: 2021-05-28
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fed Conditions

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

Eligibility criteria: Inclusion Criteria:

1. Healthy adults age≥19 years and age\<55 years at the time of screening
2. Individuals who had 17.5 kg/m2 ≤ Body Mass Index(BMI) \< 30.5kg/m2 and men's total body weight ≥ 55 kg, women's total body weight ≥ 45 kg

   \* BMI = Weight(kg)/ Height(m)2
3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination within the last 3 years
4. Individuals who were deemed to be appropriate as study subjects following laboratory tests (hematology, blood chemistry, urinalysis, viral/ bacterial, etc.) and vital signs, ECG etc. performed at screening
5. Individuals who signed an informed consent form approved by the IRB of Chonbuk National University Hospital and decided to participate in the study after being fully informed of the study prior to participation, including the objective, content and characteristics of the investigational product
6. Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of study drug infusion
7. Individuals with the ability and willingness to participate the entire study period

Exclusion Criteria:

1. Subject who has (or has histories of) clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, neurological or allergic diseases(except for asymptomatic seasonal allergy at the time of administration) or evidence(except for simple dental history such as dental calculus, impacted tooth, wisdom tooth, etc.)
2. Subject with a 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. Subject who shows the following values as a result of laboratory tests

   \*ALT or AST \> 2 times upper limit of normal range
4. Subject who has a history of regular alcohol consumption in excess of 210 g/week within 6 months of screening
5. Subject who smokes more than one pack of cigarette a day within 6 months of screening
6. Subject who took other clinical trial drugs or bioequivalence test drugs within 3 months before the first administration of clinical trial drug
7. Subject who conform to the specific items below

   * systolic blood pressure less than 90 mmHg, greater than 140 mmHg or diastolic blood pressure less than 60 mmHg or greater than 90 mmHg in a sitting position
   * Severe bradycardia (less than 50 beats/minute)
8. Subject who has significant alcohol abuse or drug abuse within a year of screening
9. Subject who took drugs which are known as disturbing drug metabolism within 30 days prior to the first administration of clinical trial drug.
10. Subject who uses any of other drugs, including over-the-counter medications and prescription medications within 10 days prior to first administration of clinical trial drug.
11. Subject who donated whole blood within 2 months prior to first administration of clinical trial drug or blood components within 1 month prior to first administration of clinical trial drug
12. Subject who is hypersensitive to the components of a clinical trial drug or clinical trial drug itself.
13. Subject had genetic dysfunctions like galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
14. Subject who is not able to consume high-fat meal provided during the clinical trial
15. Subjects who were deemed inappropriate to participate in the study by the investigator

Primary outcomes:
measure: AUCt of CKD-385
timeFrame: Pre-dose (0 hour), 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 hour), 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 hour), 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 hour), 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 hour), 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 hour), 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: Jeonju
country: Korea, Republic of
facility: National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min-Gul Kim
role: PRINCIPAL_INVESTIGATOR
References: