History of Changes for Study: NCT05992428

Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

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Study Record Versions

Version	Submitted Date	Changes
1	August 7, 2023	None (earliest Version on record)
2	August 22, 2023	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	January 24, 2024	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	DA8010_DIPM_I
Brief Title:	Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
Official Title:	An Open-label, 2-Part, Phase 1 Clinical Trial to Evaluate Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults
Secondary IDs:

Study Status


Record Verification:	August 2023
Overall Status:	Not yet recruiting
Study Start:	August 23, 2023
Primary Completion:	October 11, 2023 [Anticipated]
Study Completion:	October 27, 2023 [Anticipated]

First Submitted:	July 27, 2023
First Submitted that Met QC Criteria:	August 7, 2023
First Posted:	August 15, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 7, 2023
Last Update Posted:	August 15, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Dong-A ST Co., Ltd.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	This is an open-label, 2-Part, phase 1 study to evaluate drug interactions when DA-8010 is co-administered with Paroxetine or Mirabegron in healthy adult subjects
Detailed Description:

Conditions


Conditions:	Healthy
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
	2-part
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	36 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Part 1 or 2 [Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg	Drug: DA-8010 5mg [Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg Drug: Paroxetine 20mg [Part 1] DA-8010 5mg + Paroxetine 20mg Drug: Mirabegron 50mg [Part 2] DA-8010 5mg + Mirabegron 50mg

Outcome Measures


Primary Outcome Measures:
1.	Peak Plasma Concentration (Cmax) [ Time Frame: 0~48hours ] PK Parameter
2.	Area under the plasma concentration versus time curve of DA-8010 (AUClast) [ Time Frame: 0~48hours ] PK Parameter

Eligibility


Minimum Age:	19 Years
Maximum Age:	50 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Healthy adult volunteer 19 years to 50 years Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2 The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.) The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire Exclusion Criteria: Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease or history of such disease Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery) Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.) Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test) Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items

Contacts/Locations


Central Contact Person:	Seung Hwan Lee, PhD Telephone: 02-2072-2343 Email: leejh413@snu.ac.kr
Central Contact Backup:	Hyunwook Ryu Telephone: 02-2072-1666 Email: rhw7052@snu.ac.kr
Locations:	Korea, Republic of
	Seoul National University Hospital Soeul, Korea, Republic of

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: