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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695004
• Other study ID #: DKF-310-P1
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2016
• Source: Dongkook Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• DKF-310

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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