Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS 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: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Aricept 5mg Tablet; Drug: Aricept 10mg Tablet; Drug: DA-5207 150mg; Drug: DA-5207 170mg

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Health Voulunterrs (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

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 150mg; 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 150mg; 1 patch once weekly
Experimental: Sequence 2; Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg	Drug: Aricept 5mg Tablet; 1 tablet once daily; Drug: Aricept 10mg Tablet; 1 tablet once daily; Drug: DA-5207 150mg; 1 patch once weekly
Experimental: Sequence 3; Period 1, Aricept 5mg → DA-5207 170mg; 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 170mg; 1 patch once weekly
Experimental: Sequence 4; Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg	Drug: Aricept 5mg Tablet; 1 tablet once daily; Drug: Aricept 10mg Tablet; 1 tablet once daily; Drug: DA-5207 170mg; 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): July 28, 2020
• Primary Completion (Actual): December 9, 2020
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

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_AD_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