The Food Effect on Pharmacokinetics of DA-8010 After a Single Administration of DA-8010 2.5 mg or 5 mg in Healthy Subjects

NCT ID: NCT04686825

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2021-03-11

Brief Summary

This is a randomized, open-label, single-dose, 4-way crossover phase 1 study to evaluate the food effect on pharmacokinetics of DA-8010 after a single administration of DA-8010 2.5 mg or 5 mg under fasting and fed states in healthy male and female subjects

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

T1

DA-8010 2.5 mg (Fasting)

Group Type: EXPERIMENTAL

DA-8010 2.5mg (Fasting)

Intervention Type: DRUG

Test drug l : DA-8010 2.5mg (Fasting)

T2

DA-8010 2.5 mg (Fed)

Group Type: EXPERIMENTAL

DA-8010 2.5mg (Fed)

Intervention Type: DRUG

Test drug ll : DA-8010 2.5mg (Fed)

T3

DA-8010 5 mg (Fasting)

Group Type: EXPERIMENTAL

DA-8010 5mg (Fasting)

Intervention Type: DRUG

Test drug llI : DA-8010 5mg (Fasting)

T4

DA-8010 5 mg (Fed)

Group Type: EXPERIMENTAL

DA-8010 5mg (Fed)

Intervention Type: DRUG

Test drug lV : DA-8010 5mg (Fed)

Interventions

DA-8010 2.5mg (Fasting)

Test drug l : DA-8010 2.5mg (Fasting)

Intervention Type: DRUG

DA-8010 2.5mg (Fed)

Test drug ll : DA-8010 2.5mg (Fed)

Intervention Type: DRUG

DA-8010 5mg (Fasting)

Test drug llI : DA-8010 5mg (Fasting)

Intervention Type: DRUG

DA-8010 5mg (Fed)

Test drug lV : DA-8010 5mg (Fed)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and female volunteer 19 years to 50 years
• Body weight in the range of 45.0 to 90.0 kg and body mass index in the range of 18 to 30kg/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
• 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 Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
• 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 who have blood pressure < 90 mmHg or >150 mmHg as systolic or <60 mmHg or >100 mmHg as diastolic
• Subject who have history of drug abuse or Positive in Urine drug screen test
• Subject who are Positivie in Alcohol breath test on screening
• Subject who have ETC drug or oriental medicine 2 weeks prior to IP administration or OTC drug or health functional food or vitamins 1 week prior to IP administration
• Subject who have taken a drug that induces or inhibits the drug metabolic enzyme (e.g., barbital) within 30 days prior to IP administration
• Subject who have participated in other clinical trials within 6 months prior to the first administration of the IP
• Subject who have had whole blood transfusion within 2 months or the apheresis within 2 weeks prior to the first administration of the IP
• Subject with a history of regular alcohol intake(>21 units/week , 1 unit = 10 g of pure alcohol) or who are unable to quit alcohol from 3 days prior to the first administration of the IP until out of hospital
• Smoker(excluding who quit smoking 3 months before this clinical trial) or subject who are unable to quit smoking from 3 days prior to first administration of the IP until out of hospital
• Subject who are unable to quit food containing grapefruit from 3 days before first administration of the IP until out of hospital
• Subject who regularly intake caffeine(> 5 units/day) or who are unable to quit caffeine/food containing caffeine from 3 days before first administration of the IP until out of hospital
• Subject with unusual eating habits (continuous vegetarian diet, etc.) or who are unable to consume the entire diet provided in this clinical trial
• Subject who are positive in pregnancy test or pregnant or Lactating women
• Subject who do not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the IP until the 4 weeks after the last administration.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seung Hwan Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

SNUH Clinical Pharmacololgy and Therapeutics

Locations

Seoul National University Hospital

Soeul, , South Korea

Countries

South Korea

Other Identifiers

DA8010_DIF_I

Identifier Type: -

Identifier Source: org_study_id