Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DA-8010 5mg; Drug: Clarithromycin 500mg; Drug: Rifampicin 600mg

• Registration Number: NCT05991401
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-14
• Study Start: 2023-08-18
• Primary Completion: 2023-11-06
• Study Completion: 2023-11-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Period 1 or 2 or 3	DA-8010 5mg	\[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg
Period 1 or 2 or 3	Rifampicin 600mg	\[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg
Period 1 or 2 or 3	Clarithromycin 500mg	\[Period 1\] DA-8010 5mg \[Period 2\] DA-8010 5mg, Clarithromycin 500mg \[Period 3\] DA-8010 5mg, Rifampicin 600mg

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration of DA-8010 (Cmax)	0~48hours
Area under the plasma concentration versus time curve of DA-8010 (AUClast)	0~48hours

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of