NCT05108038

Brief Summary

to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 14, 2021

Last Update Submit

October 24, 2021

Conditions

GERD

Keywords

CKD-382D860D027

Outcome Measures

Primary Outcomes (2)

  • Primary Pharmacokinetic Endpoint

    AUCt,ss Evaluation after multiple dose -AUCt,ss: Area under the plasma drug concentration-time curve within a dosing interval in steady-state

    0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours

  • Primary Pharmacodynamic Endpoint

    Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose

    24 hours after multiple dose for 7 days compared to baseline

Secondary Outcomes (15)

  • (1) Secondary Pharmacokinetic Endpoint

    0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours

  • (1) Secondary Pharmacokinetic Endpoint

    0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours

  • (1) Secondary Pharmacokinetic Endpoint

    0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours

  • (1) Secondary Pharmacokinetic Endpoint

    0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours

  • (1) Secondary Pharmacokinetic Endpoint

    0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours

  • +10 more secondary outcomes

Study Arms (6)

A

EXPERIMENTAL

Period 1: CKD-382 Period 2: D860 Period 3: D027

Drug: CKD-382, D860, D027

B

EXPERIMENTAL

Period 1: CKD-382 Period 2: D027 Period 3: D860

Drug: CKD-382, D860, D027

C

EXPERIMENTAL

Period 1: D860 Period 2: D027 Period 3: CKD-382

Drug: CKD-382, D860, D027

D

EXPERIMENTAL

Period 1: D860 Period 2: CKD-382 Period 3: D027

Drug: CKD-382, D860, D027

E

EXPERIMENTAL

Period 1: D027 Period 2: D860 Period 3: CKD-382

Drug: CKD-382, D860, D027

F

EXPERIMENTAL

Period 1: D027 Period 2: CKD-382 Period 3: D860

Drug: CKD-382, D860, D027

Interventions

CKD-382, D860, D027DRUG

QD, PO for 7days

ABCDEF

Eligibility Criteria

Age19 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 19 aged and 50 aged in healthy adult
  • Body weight more than 50kg
  • BMI more than 18.0 and under 27.0
  • Who has negative result on Helicobacter Pylori antibody test

You may not qualify if:

  • Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease
  • Have a gastrointestinal disease history(including surgery) that can effect drug absorption
  • Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk Ntional University Hospital

Cheongju-si, South Korea

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Minkyu Park, Ph.D

CONTACT

043-269-8708mk_park@cbnuhctc.com

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

October 14, 2021

First Posted

November 4, 2021

Study Start

October 7, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)