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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05991401
• Other study ID #: DA8010_DICR_I
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2023
• Est. completion date: November 17, 2023

Study information

• Verified date: January 2024
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 17, 2023
• Est. primary completion date: November 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration of DA-8010 (Cmax)		0~48hours
Primary	Area under the plasma concentration versus time curve of DA-8010 (AUClast)		0~48hours