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

April 2, 2020 updated by: Dongkook Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donepezil 35 mg
Donepezil 35 mg or placebo
Drug: Placebo
Drug: DKF-310
Other Names:
  • Donepezil
Experimental: Donepezil 70 mg
Donepezil 70 mg or placebo
Drug: Placebo
Drug: DKF-310
Other Names:
  • Donepezil
Experimental: Donepezil140 mg
Donepezil 140 mg or placebo
Drug: Placebo
Drug: DKF-310
Other Names:
  • Donepezil
Experimental: Donepezil 210 mg
Donepezil 210 mg or placebo
Drug: Placebo
Drug: DKF-310
Other Names:
  • Donepezil
Experimental: Donepezil 280 mg
Donepezil 280 mg or placebo
Drug: Placebo
Drug: DKF-310
Other Names:
  • Donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 1056h
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
Time Frame: 1056h
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DKF-310-P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe