NCT04654065

Brief Summary

To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2021

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

November 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2021

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1 day

First QC Date

November 29, 2020

Last Update Submit

January 27, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • AUCt of tegoprazan

    Area under the plasma concentration-time curve of tegoprazan

    pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

  • Cmax of tegoprazan

    Maximum Plasma Concentration at Steady State of tegoprazan

    pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

  • Tmax of tegoprazan

    Time to reach Cmax

    pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours

Study Arms (1)

IN-C004

EXPERIMENTAL

IN-C004

Drug: IN-C004

Interventions

IN-C004DRUG

One time dose of IN-C004 taken orally.

IN-C004

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.

You may not qualify if:

  • History or evidence of clinically significant disease
  • History of drug/alcohol abuse
  • Participated in other studies and received investigational products within 6 months prior to the first study dose.
  • Not able to use a medically acceptable contraceptive method throughout the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, South Korea

Location

Study Officials

  • Min-Gul Kim

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2020

First Posted

December 4, 2020

Study Start

January 4, 2021

Primary Completion

January 5, 2021

Study Completion

January 5, 2021

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

KR(1)