NCT04830930

Brief Summary

A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2021

Completed
Last Updated

August 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

April 1, 2021

Last Update Submit

August 17, 2021

Conditions

GERD

Keywords

CKD-381

Outcome Measures

Primary Outcomes (3)

  • Cmax

    maximum observed concentration after dose

    0-24 hours

  • AUClast

    Area under the plasma concentration versus time curve over the dosing interval after dose

    0-24 hours

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

    0-24 hours

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1: fasted condition/ Period 2: fed condition

Drug: CKD-381

Sequence 2

EXPERIMENTAL

Period 1: fed condition/ Period 2: fasted condition

Drug: CKD-381

Interventions

CKD-381DRUG

single-dose, oral administration of CKD-381 1 tablet

Sequence 1Sequence 2

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 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2
  • Have 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 evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product.
  • Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Kyungsang Yu, M.D., Ph.D.

    ksyu@snu.ac.kr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2021

First Posted

April 5, 2021

Study Start

April 21, 2021

Primary Completion

June 17, 2021

Study Completion

July 26, 2021

Last Updated

August 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)