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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DKF-310
Placebo
Sponsored by
Dongkook Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer's Disease

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul National Univ. Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Donepezil 35 mg

Donepezil 70 mg

Donepezil140 mg

Donepezil 210 mg

Donepezil 280 mg

Arm Description

Donepezil 35 mg or placebo

Donepezil 70 mg or placebo

Donepezil 140 mg or placebo

Donepezil 210 mg or placebo

Donepezil 280 mg or placebo

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
February 18, 2016
Last Updated
April 2, 2020
Sponsor
Dongkook Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02695004
Brief Title
Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
Official Title
Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongkook Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Donepezil 35 mg
Arm Type
Experimental
Arm Description
Donepezil 35 mg or placebo
Arm Title
Donepezil 70 mg
Arm Type
Experimental
Arm Description
Donepezil 70 mg or placebo
Arm Title
Donepezil140 mg
Arm Type
Experimental
Arm Description
Donepezil 140 mg or placebo
Arm Title
Donepezil 210 mg
Arm Type
Experimental
Arm Description
Donepezil 210 mg or placebo
Arm Title
Donepezil 280 mg
Arm Type
Experimental
Arm Description
Donepezil 280 mg or placebo
Intervention Type
Drug
Intervention Name(s)
DKF-310
Other Intervention Name(s)
Donepezil
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
AUC
Description
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
Time Frame
1056h
Title
Cmax
Description
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
Time Frame
1056h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Seoul National Univ. Bundang Hospital
City
Seongnam
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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