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Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 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: NCT05991401
Recruitment Status : Completed
First Posted : August 14, 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, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.

Condition or disease Intervention/treatment Phase
Healthy Drug: DA-8010 5mg Drug: Clarithromycin 500mg Drug: Rifampicin 600mg Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 3-period
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Fixed-sequence, Phase 1 Clinical Trial to Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults
Actual Study Start Date : August 18, 2023
Actual Primary Completion Date : November 6, 2023
Actual Study Completion Date : November 17, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Period 1 or 2 or 3
[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg
 Drug: DA-8010 5mg
[Period 1] DA-8010 5mg [Period 2] DA-8010 5mg, Clarithromycin 500mg [Period 3] DA-8010 5mg, Rifampicin 600mg

Drug: Clarithromycin 500mg
[Period 2] DA-8010 5mg, Clarithromycin 500mg

Drug: Rifampicin 600mg
[Period 3] DA-8010 5mg, Rifampicin 600mg


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

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
  • 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 personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
  • 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, sexual disorder, ophthalmologic 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 appendix 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): NCT05991401


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, 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: NCT05991401    
Other Study ID Numbers: DA8010_DICR_I
First Posted: August 14, 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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Clarithromycin
Rifampin
DA-8010
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
 Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs