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

• ClinicalTrials.gov Identifier: NCT05992428
• Recruitment Status: Completed
• First Posted: August 15, 2023
• Last Update Posted: January 25, 2024
• Sponsor: Dong-A ST Co., Ltd.
• Information provided by (Responsible Party): Dong-A ST Co., Ltd.

Tracking Information

• First Submitted Date: July 27, 2023
• First Posted Date: August 15, 2023
• Last Update Posted Date: January 25, 2024
• Actual Study Start Date: August 22, 2023
• Actual Primary Completion Date: November 7, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 7, 2023)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

2-part

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Healthy

Intervention

• 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

Study Arms

Experimental: Part 1 or 2

[Part 1] DA-8010 5mg + Paroxetine 20mg [Part 2] DA-8010 5mg + Mirabegron 50mg

Interventions:

• Drug: DA-8010 5mg
• Drug: Paroxetine 20mg
• Drug: Mirabegron 50mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2024): 37
• Original Estimated Enrollment (submitted: August 7, 2023): 36
• Actual Study Completion Date: December 5, 2023
• Actual Primary Completion Date: November 7, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05992428
• Other Study ID Numbers: DA8010_DIPM_I
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dong-A ST Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Dong-A ST Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Dong-A ST Co., Ltd.
• Verification Date: January 2024