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

NCT05992428 | Completed Phase 1 DMC

• 1 other identifier: DA8010_DIPM_I
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  PK Parameter

  0~48hours

• Area under the plasma concentration versus time curve of DA-8010 (AUClast)

  PK Parameter

  0~48hours

Study Arms (1)

Part 1 or 2

EXPERIMENTAL

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

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

Interventions

DA-8010 5mg DRUG

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

Part 1 or 2

Paroxetine 20mg DRUG

\[Part 1\] DA-8010 5mg + Paroxetine 20mg

Part 1 or 2

Mirabegron 50mg DRUG

\[Part 2\] DA-8010 5mg + Mirabegron 50mg

Part 1 or 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Soeul, South Korea

Location

MeSH Terms

Interventions

DA-8010; Paroxetine; mirabegron

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-part

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 15, 2023
• Study Start: August 22, 2023
• Primary Completion: November 7, 2023
• Study Completion: December 5, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

KR (1)