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

Sponsor

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

Overall Status

Active, not recruiting

CT.gov ID

NCT04479865

Collaborator

(none)

Enrollment

Location

Arms

9.1

Anticipated Duration (Months)

5.4

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 150mg Drug: DA-5207 170mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

49 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

Actual Study Start Date :

Jul 28, 2020

Actual Primary Completion Date :

Dec 9, 2020

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

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

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 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

Contacts and Locations

Locations

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

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:

NCT04479865

Other Study ID Numbers:

DA5207_AD_Ib

First Posted:

Jul 21, 2020

Last Update Posted:

Apr 15, 2021

Last Verified:

Apr 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 Apr 15, 2021