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

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 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: DA-8010 2.5mg (Fasting); Drug: DA-8010 2.5mg (Fed); Drug: DA-8010 5mg (Fasting); Drug: DA-8010 5mg (Fed)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: T1; DA-8010 2.5 mg (Fasting)	Drug: DA-8010 2.5mg (Fasting); Test drug l : DA-8010 2.5mg (Fasting)
EXPERIMENTAL: T2; DA-8010 2.5 mg (Fed)	Drug: DA-8010 2.5mg (Fed); Test drug ll : DA-8010 2.5mg (Fed)
EXPERIMENTAL: T3; DA-8010 5 mg (Fasting)	Drug: DA-8010 5mg (Fasting); Test drug llI : DA-8010 5mg (Fasting)
EXPERIMENTAL: T4; DA-8010 5 mg (Fed)	Drug: DA-8010 5mg (Fed); Test drug lV : DA-8010 5mg (Fed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	PK parameter	0~48hours
Area under the plasma concentration versus time curve (AUClast)	PK parameter	0~48hours

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Seung Hwan Lee, PhD, SNUH Clinical Pharmacololgy and Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ACTUAL): February 17, 2021
• Study Completion (ACTUAL): March 11, 2021

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 26, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; DA-8010
• Other Study ID Numbers: DA8010_DIF_I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No