NCT03802162

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

January 10, 2019

Last Update Submit

October 21, 2019

Conditions

Alzheimer's Disease (AD)

Keywords

Alzheimer's diseaseCKD-355

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Cmin of D324

    0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

  • Cmin of D797

    0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

  • Tmax of D324

    0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

  • Tmax of D797

    0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

  • t½ of D324

    0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours

  • +1 more secondary outcomes

Study Arms (3)

CKD-355A

EXPERIMENTAL
Drug: CKD-355A (D797/Memantine HCl 20mg)

CKD-355B

EXPERIMENTAL
Drug: CKD-355B (D797/Memantine HCl 20mg)

D797, D324

ACTIVE COMPARATOR
Drug: D797Drug: D324 (Memantine HCl 10mg)

Interventions

CKD-355A (D797/Memantine HCl 20mg)DRUG

once a day

CKD-355A
CKD-355B (D797/Memantine HCl 20mg)DRUG

once a day

CKD-355B
D797DRUG

once a day

D797, D324
D324 (Memantine HCl 10mg)DRUG

twice a day

D797, D324

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult older than 19 years and less than 55 years at the time of screening
  • BMI 18.5\~29.9 kg/m2 and body weight more than 50kg
  • 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
  • Subjects who sign on an informed consent form willingly

You may not qualify if:

  • Subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease.
  • Subjects who have acute disease within 28 days prior to the first administration
  • Subjects who have history that may affect the ADME
  • Subjects who have clinically significant chronic disease
  • Women who are nursing, pregnant or positive on pregnancy test
  • Subjects who have clinically significant allergic diseases
  • Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Subjects who are known to be hypersensitive to the drug or its components
  • Subjects who have been found to be positive in serological tests (HBs antigen, HCV antibody and HIV antibody)
  • Subjects with creatinine clearance \<60 ml / min
  • Subjects whose AST or ALT levels exceeded 2.5 times of upper limit of normal range
  • 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
  • Subjects who can not eat standard meals provided by the institution.
  • Subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days
  • Subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

February 15, 2019

Primary Completion

May 10, 2019

Study Completion

August 31, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

KR(1)