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Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

Sponsor
Dong-A ST Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04013477
Collaborator
(none)
40
Enrollment
1
Location
4
Arms
9.6
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 18, 2019
Actual Primary Completion Date :
Dec 5, 2019
Actual Study Completion Date :
Apr 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort1

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

Drug: DA-5207
DA-5207 Transdermal Delivery System
Experimental: Cohort2

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

Drug: DA-5207
DA-5207 Transdermal Delivery System
Experimental: Cohort3

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

Drug: DA-5207
DA-5207 Transdermal Delivery System
Active Comparator: Cohort4

drug : Aricept

Drug: Donepezil Hydrochloride
donepezil HCl 10mg QD
Other Names:
  • Aricept

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUC [patch : 21days, oral : 11days]

      area under the concentration-time curve

    2. Cmax [patch : 21days, oral : 11days]

      maximum serum concentration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Health Male Volunteers (Age : 19~55 years)

    • Body Weight : Male≥55kg, Female≥50kg

    • 18.5≤BMI<25.0

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trials Center, Severance Hospital Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Dong-A ST Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A ST Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04013477
    Other Study ID Numbers:
    • DA5207_ADK_Ia
    First Posted:
    Jul 9, 2019
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Donepezil

    Study Results

    No Results Posted as of Apr 14, 2021