Phase 1 Clinical Trial of DA-5207 in Healthy Adults

An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 A; Drug: DA-5207 B

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Seol Ju Moon, M.D., Ph.D.; Phone Number: +82-63-259-3500; Email: sjmoon@jbcp.kr

Study Locations

• Korea, Republic of
  • Jeonbuk
    • Jeonju, Jeonbuk, Korea, Republic of, 54907
      • Jeonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Health 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 caffeine intake
• Heavy alcohol intake (more than 210g/week)
• Heavy smoker (more than 10 cigarettes/day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1, Aricept 5mg → DA-5207 A; Period 2, Aricept 5mg → Aricept 10mg	Drug: Aricept 5mg Tablet; 1 tablet once daily; Drug: Aricept 10mg Tablet; 1 tablet once daily; Drug: DA-5207 A; 1 patch once weekly
Experimental: Sequence 2; Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 A	Drug: Aricept 5mg Tablet; 1 tablet once daily; Drug: Aricept 10mg Tablet; 1 tablet once daily; Drug: DA-5207 A; 1 patch once weekly
Experimental: Sequence 3; Period 1, Aricept 5mg → DA-5207 B; Period 2, Aricept 5mg → Aricept 10mg	Drug: Aricept 5mg Tablet; 1 tablet once daily; Drug: Aricept 10mg Tablet; 1 tablet once daily; Drug: DA-5207 B; 1 patch once weekly
Experimental: Sequence 4; Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 B	Drug: Aricept 5mg Tablet; 1 tablet once daily; Drug: Aricept 10mg Tablet; 1 tablet once daily; Drug: DA-5207 B; 1 patch once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	area under the concentration-time curve	29-36 days
Css,max	maximum serum concentration at steady state	0-36 days

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: DA5207_AD2_Ib

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No