Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).

NCT02695004 | Completed Phase 1 DMC

• 1 other identifier: DKF-310-P1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• AUC

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h

  1056h

• Cmax

  0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h

  1056h

Study Arms (5)

Donepezil 35 mg

EXPERIMENTAL

Donepezil 35 mg or placebo

Drug: DKF-310; Drug: Placebo

Donepezil 70 mg

EXPERIMENTAL

Donepezil 70 mg or placebo

Drug: DKF-310; Drug: Placebo

Donepezil140 mg

EXPERIMENTAL

Donepezil 140 mg or placebo

Drug: DKF-310; Drug: Placebo

Donepezil 210 mg

EXPERIMENTAL

Donepezil 210 mg or placebo

Drug: DKF-310; Drug: Placebo

Donepezil 280 mg

EXPERIMENTAL

Donepezil 280 mg or placebo

Drug: DKF-310; Drug: Placebo

Interventions

DKF-310 DRUG

Also known as: Donepezil

Donepezil 210 mg; Donepezil 280 mg; Donepezil 35 mg; Donepezil 70 mg; Donepezil140 mg

Placebo DRUG

Donepezil 210 mg; Donepezil 280 mg; Donepezil 35 mg; Donepezil 70 mg; Donepezil140 mg

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men aged 19 to 50 years
• Body weight 55 to 90 kg and BMI 18.0 to 27.0
• Voluntarily signed the informed consent form
• Eligible according to the screening test results
• Available to follow up after drop-out

You may not qualify if:

• Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
• Hypersensitivity to donepezil, piperidine derivatives and other drugs
• SBP \<100 mmHg or \>150 mmHg, or DBP \<60 mmHg or \>100 mmHg
• Skin and muscle disorders or history of surgery at the injection site
• AST or ALT \>1.5xULN; QT/QTcB interval \>450 ms
• History or positive result of drug abuse
• Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week
• Participated in other clinical trials within 3 months
• Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
• Alcohol consumption \>21 units/week
• Smoked \>10 cigarettes/day within 3 months
• Caffeine-containing foods
• Not eligible due to other reasons at the investigator's discretion

Sponsors & Collaborators

• Dongkook Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 1, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 6, 2020

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)