A Clinical Trial to Compare the Safety, Tolerability, and PK Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216.

A Randomized, Open-label, Single Dose, Cross-over Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetic Properties of DA-5216 and DA-5216-R and to Evaluate the Food Effect on DA-5216 in Healthy Adult Subjects.

This is a randomized, open-label, single dose, 2-part, cross-over clinical trial to compare the safety, tolerability, and pharmacokinetic properties of DA-5216 and DA-5216-R and to evaluate the food effect on DA-5216 in healthy adult subjects

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: DA-5216; Drug: DA-5216; Drug: DA-5216-R

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Seung Hwan Lee, PhD; Phone Number: 02-2072-2343; Email: leejh413@snu.ac.kr

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Seung Hwan Lee, PhD

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 50.0kg and body mass index in the range of 18 to 27kg/m2
• Subject who are negative in pregnancy test or pregnant or Lactating women
• 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, respiratory, digestive, hematologic, endocrine(diabetes mellitus, aldosteronism), immunologic, cardiovascular(hypertension, angina, heart failure, myocardial infarction, etc.), neurologic, urologic, otorhinolaryngologic, musculoskeletal, psychological disease or history of such disease
• Subject with gastrointestinal disease (Crohn's disease, peptic ulcer, acute or chronic pancreatitis, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery).
• Subject who have galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption

• Subject who have had one or more of the following findings

  • AST, ALT > 1.5 times the upper limit
  • CPK > 2.5 times the upper limit
  • eGFR <60mL/min/1.73m2

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: [Part A] DA-5216	Drug: DA-5216; During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.; Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.; Drug: DA-5216; During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216(Fed) on Day 8.; Sequence II. Single dose of DA-5216(Fed) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.
EXPERIMENTAL: [Part A] DA-5216-R	Drug: DA-5216-R; During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.; Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.
EXPERIMENTAL: [Part B] DA-5216(Fasting)	Drug: DA-5216; During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.; Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.; Drug: DA-5216; During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216(Fed) on Day 8.; Sequence II. Single dose of DA-5216(Fed) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.
EXPERIMENTAL: [Part B] DA-5216(Fed)	Drug: DA-5216; During the cross-over [Part A], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216-R(Fasting) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.; Sequence II. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216-R(Fasting) on Day 8.; Drug: DA-5216; During the cross-over [Part B], patients will be randomly assigned to receive one of the following treatment sequences: Sequence I. Single dose of DA-5216(Fasting) on Day 1 followed by a single dose of DA-5216(Fed) on Day 8.; Sequence II. Single dose of DA-5216(Fed) on Day 1 followed by a single dose of DA-5216(Fasting) on Day 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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): August 29, 2022
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (ACTUAL): August 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DA5216_BE_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