Clinical trial NCT03802162: A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355
Official title: An Open-label, Randomized, Multiple-dosing Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355 With D797 and D324 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease (AD)
Keywords: Alzheimer's disease
CKD-355
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of CKD-355.

Detailed description: An open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of CKD-355 with D797 and D324 in healthy subjects

Eligibility criteria: Inclusion Criteria:

1. Healthy adult older than 19 years and less than 55 years at the time of screening
2. BMI 18.5\~29.9 kg/m2 and body weight more than 50kg
3. Subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men
4. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
2. Subjects who have acute disease within 28 days prior to the first administration
3. Subjects who have history that may affect the ADME
4. Subjects who have clinically significant chronic disease
5. Women who are nursing, pregnant or positive on pregnancy test
6. Subjects who have clinically significant allergic diseases
7. Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
8. Subjects who are known to be hypersensitive to the drug or its components
9. Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
10. Subjects with creatinine clearance \<60 ml / min
11. Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
12. Subjects who taked ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 1 week prior to the first administration
13. Subjects who can not eat standard meals provided by the institution.
14. Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
15. Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
16. Subjects who have had abnormal diets that can affect the ADME of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice\>1 L / day)
17. Subjects who participate in the other clinical trial within 90 days prior to the first administration
18. Subjects who have a history of regular alcohol(alcohol\>210g/week) or caffeine(caffeine\>5 cups/day)
19. Subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial
20. Subjects who is determined unsuitable to participate in this clinical trial by the investigator

Primary outcomes:
measure: Cmax of D324
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: AUCt of D324
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: Cmax of D797
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: AUCt of D797
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Secondary outcomes:
measure: Cmin of D324
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: Cmin of D797
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: Tmax of D324
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: Tmax of D797
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: t½ of D324
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
measure: t½ of D797
timeFrame: 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References: