Phase 1 Clinical Trial to Evaluate the Safety, PK and PD Profiles of DA-5207 TDS in Healthy Adults

Sponsor

Dong-A ST Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05127746

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Aricept 5mg Tablet Drug: Aricept 10mg Tablet Drug: DA-5207 A Drug: DA-5207 B	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

AUC [29-36 days]
area under the concentration-time curve
Css,max [0-36 days]
maximum serum concentration at steady state

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jeonbuk National University Hospital	Jeonju	Jeonbuk	Korea, Republic of	54907

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:

NCT05127746

Other Study ID Numbers:

DA5207_AD2_Ib

First Posted:

Nov 19, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Donepezil

Study Results

No Results Posted as of Nov 19, 2021