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

NCT05991401 | Completed Phase 1

• 1 other identifier: DA8010_DICR_I
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration of DA-8010 (Cmax)

  0~48hours

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

  0~48hours

Study Arms (1)

Period 1 or 2 or 3

EXPERIMENTAL

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

Drug: DA-8010 5mg; Drug: Clarithromycin 500mg; Drug: Rifampicin 600mg

Interventions

DA-8010 5mg DRUG

\[Period 1\] 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 DRUG

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

Period 1 or 2 or 3

Rifampicin 600mg DRUG

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

Period 1 or 2 or 3

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
• 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

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, 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

DA-8010; Clarithromycin; Rifampin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic 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: 3-period

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: August 18, 2023
• Primary Completion: November 6, 2023
• Study Completion: November 17, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

KR (1)