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Status unknownNCT05506007Updated Sep 23, 2022

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 Phase 1 interventional study of DA-5216 and DA-5216-R in Healthy, sponsored by Dong-A ST Co., Ltd.. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by Dong-A ST Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    [Part A] DA-5216

    Drug: DA-5216

  • Experimental
    [Part A] DA-5216-R

    Drug: DA-5216-R

  • Experimental
    [Part B] DA-5216(Fasting)

    Drug: DA-5216

  • Experimental
    [Part B] DA-5216(Fed)

    Drug: DA-5216

Interventions

  • DrugDA-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.

  • DrugDA-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.

  • DrugDA-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.

  • DrugDA-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.

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax) PK parameter

    Time frame: 0~48hours

  2. Area under the plasma concentration versus time curve (AUClast) PK parameter

    Time frame: 0~48hours

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Soeul, Korea, Republic of
    • Seung Hwan Lee, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05506007
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Aug 18, 2022
Start date
Aug 29, 2022
Primary completion
Oct 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Sep 23, 2022

Study contacts

Seung Hwan Lee, PhD
Contact
leejh413@snu.ac.kr
02-2072-2343
Seung Hwan Lee, PhD
principal investigator · SNUH Clinical Pharmacololgy and Therapeutics

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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