NCT04013477

Brief Summary

A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

June 26, 2019

Last Update Submit

April 13, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC

    area under the concentration-time curve

    patch : 21days, oral : 11days

  • Cmax

    maximum serum concentration

    patch : 21days, oral : 11days

Study Arms (4)

Cohort1

EXPERIMENTAL

drug : DA-5207 80mg/40cm² placebo : 40cm²

Drug: DA-5207

Cohort2

EXPERIMENTAL

drug : DA-5207 120mg/60cm² placebo : 60cm²

Drug: DA-5207

Cohort3

EXPERIMENTAL

drug : DA-5207 160mg/80cm² placebo : 80cm²

Drug: DA-5207

Cohort4

ACTIVE COMPARATOR

drug : Aricept

Drug: Donepezil Hydrochloride

Interventions

DA-5207DRUG

DA-5207 Transdermal Delivery System

Cohort1Cohort2Cohort3
Donepezil HydrochlorideDRUG

donepezil HCl 10mg QD

Also known as: Aricept
Cohort4

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Health Male Volunteers (Age : 19\~55 years)
  • Body Weight : Male≥55kg, Female≥50kg
  • ≤BMI\<25.0

You may not qualify if:

  • Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History
  • AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73m²
  • Heavy alcohol intake (more than 210g/week)
  • Heavy smoker (more than 10 cigarettes/day)
  • Heavy caffeine intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

Donepezil

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 9, 2019

Study Start

June 18, 2019

Primary Completion

December 5, 2019

Study Completion

April 6, 2020

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations

KR(1)