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Completed

NCT Number: NCT02695004

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National Univ. Bundang Hospital

Seongnam, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DKF-310

Drug

Other names: Donepezil

Placebo

Drug

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Dongkook Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2016
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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