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.

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506007
• Other study ID #: DA5216_BE_I
• Status: Recruiting
• Phase: Phase 1
• Start date: August 29, 2022
• Est. completion date: October 2022

Study information

• Verified date: August 2022
• Source: Dong-A ST Co., Ltd.
• Contact: Seung Hwan Lee, PhD
• Phone: 02-2072-2343
• Email: leejh413[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Soeul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax) PK parameter		0~48hours
Primary	Area under the plasma concentration versus time curve (AUClast) PK parameter		0~48hours