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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05992428
Recruitment Status : Completed
First Posted : August 15, 2023
Last Update Posted : January 25, 2024
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Drug: DA-8010 5mg Drug: Paroxetine 20mg Drug: Mirabegron 50mg Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 2-part
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 22, 2023
Actual Primary Completion Date : November 7, 2023
Actual Study Completion Date : December 5, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
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
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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 Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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 and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05992428


Locations
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Korea, Republic of
Seoul National University Hospital
Soeul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
More Information
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT05992428    
Other Study ID Numbers: DA8010_DIPM_I
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: January 25, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paroxetine
Mirabegron
DA-8010
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
 Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents