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)
48
Enrollment
1
Location
4
Arms
11
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. AUC [29-36 days]

    area under the concentration-time curve

  2. 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

SiteCityStateCountryPostal Code
1Jeonbuk National University HospitalJeonjuJeonbukKorea, Republic of54907

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:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2021