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.

NCT05506007 | Unknown Phase 1

• 1 other identifier: DA5216_BE_I
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

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)

[Part A] DA-5216

EXPERIMENTAL

Drug: DA-5216

[Part A] DA-5216-R

EXPERIMENTAL

Drug: DA-5216-R

[Part B] DA-5216(Fasting)

EXPERIMENTAL

Drug: DA-5216

[Part B] DA-5216(Fed)

EXPERIMENTAL

Drug: DA-5216

Interventions

DA-5216 DRUG

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.

[Part A] DA-5216

DA-5216-R DRUG

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.

[Part A] DA-5216-R

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Soeul, South Korea

RECRUITING

Study Officials

• Seung Hwan Lee, PhD

  SNUH Clinical Pharmacololgy and Therapeutics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Hwan Lee, PhD

CONTACT

02-2072-2343; leejh413@snu.ac.kr

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: August 16, 2022
• First Posted: August 18, 2022
• Study Start: August 29, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-08

Locations

KR (1)