Single-ascending Dose Phase 1 Clinical Trial to Evaluate... | NCT04013477

Studies
Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

NCT04013477

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Apr 14, 2021Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

DA-5207
Donepezil Hydrochloride

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2019Actual

Primary Completion Date

Dec 5, 2019Actual

Completion Date

Apr 6, 2020Actual

First Submitted Date

Jun 26, 2019

First Submission Date that Met QC Criteria

Jul 8, 2019

First Posted Date

Jul 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2021

Last Update Posted Date

Apr 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort1	Experimental	drug : DA-5207 80mg/40cm² placebo : 40cm²	Drug: DA-5207
Cohort2	Experimental	drug : DA-5207 120mg/60cm² placebo : 60cm²	Drug: DA-5207
Cohort3	Experimental	drug : DA-5207 160mg/80cm² placebo : 80cm²	Drug: DA-5207
Cohort4	Active Comparator	drug : Aricept	Drug: Donepezil Hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5207	Drug	DA-5207 Transdermal Delivery System	Cohort1 Cohort2 Cohort3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC	area under the concentration-time curve	patch : 21days, oral : 11days
Cmax	maximum serum concentration	patch : 21days, oral : 11days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Center, Severance Hospital		Seoul		03722	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D000077265	Donepezil

Ancestor Terms

ID	Term
D007189	Indans
D007192	Indenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided