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

NCT04686825 | Completed Phase 1

• 1 other identifier: DA8010_DIF_I
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  PK parameter

  0~48hours

• Area under the plasma concentration versus time curve (AUClast)

  PK parameter

  0~48hours

Study Arms (4)

T1

EXPERIMENTAL

DA-8010 2.5 mg (Fasting)

Drug: DA-8010 2.5mg (Fasting)

T2

EXPERIMENTAL

DA-8010 2.5 mg (Fed)

Drug: DA-8010 2.5mg (Fed)

T3

EXPERIMENTAL

DA-8010 5 mg (Fasting)

Drug: DA-8010 5mg (Fasting)

T4

EXPERIMENTAL

DA-8010 5 mg (Fed)

Drug: DA-8010 5mg (Fed)

Interventions

DA-8010 2.5mg (Fasting) DRUG

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

T1

DA-8010 2.5mg (Fed) DRUG

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

T2

DA-8010 5mg (Fasting) DRUG

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

T3

DA-8010 5mg (Fed) DRUG

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

T4

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Soeul, South Korea

Location

MeSH Terms

Interventions

DA-8010

Study Officials

• Seung Hwan Lee, PhD

  SNUH Clinical Pharmacololgy and Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: January 13, 2021
• Primary Completion: February 17, 2021
• Study Completion: March 11, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-01

Locations

KR (1)