A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-355

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

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

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease (AD)
• Intervention / Treatment: Drug: CKD-355A (D797/Memantine HCl 20mg); Drug: CKD-355B (D797/Memantine HCl 20mg); Drug: D797; Drug: D324 (Memantine HCl 10mg)

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CKD-355A	Drug: CKD-355A (D797/Memantine HCl 20mg); once a day
EXPERIMENTAL: CKD-355B	Drug: CKD-355B (D797/Memantine HCl 20mg); once a day
ACTIVE_COMPARATOR: D797, D324	Drug: D797; once a day; Drug: D324 (Memantine HCl 10mg); twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of D324	Max Concentration of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
AUCt of D324	Area under the curve of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmax of D797	Max Concentration of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
AUCt of D797	Area under the curve of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmin of D324	Min Concentration of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Cmin of D797	Min Concentration of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D324	Time of Max concentration of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
Tmax of D797	Time of Max concentration of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D324	Half-life time of D324	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours
t½ of D797	Half-life time of D797	0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): May 10, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (ACTUAL): January 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Alzheimer's disease; CKD-355
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Memantine
• Other Study ID Numbers: 179BE18029

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No