Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers

To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

Detailed Description

An Open-label, Randomized, Single-dose, Crossover Study

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
• AST(GOT) or ALT(GPT) > 2 X upper limit of normal at screening
• Not able to use a medically acceptable contraceptive method throughout the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1	Drug: IN-C004 with water; One time dose of IN-C004 taken with water; Other Names: IN-C004; Drug: IN-C004 without water; One time dose of IN-C004 taken without water; Other Names: IN-C004; Drug: K-CAB tab. with water; One time dose of K-CAB tab. taken with water; Other Names: K-CAB tab.
EXPERIMENTAL: Group 2	Drug: IN-C004 with water; One time dose of IN-C004 taken with water; Other Names: IN-C004; Drug: IN-C004 without water; One time dose of IN-C004 taken without water; Other Names: IN-C004; Drug: K-CAB tab. with water; One time dose of K-CAB tab. taken with water; Other Names: K-CAB tab.
EXPERIMENTAL: Group 3	Drug: IN-C004 with water; One time dose of IN-C004 taken with water; Other Names: IN-C004; Drug: IN-C004 without water; One time dose of IN-C004 taken without water; Other Names: IN-C004; Drug: K-CAB tab. with water; One time dose of K-CAB tab. taken with water; Other Names: K-CAB tab.
EXPERIMENTAL: Group 4	Drug: IN-C004 with water; One time dose of IN-C004 taken with water; Other Names: IN-C004; Drug: IN-C004 without water; One time dose of IN-C004 taken without water; Other Names: IN-C004; Drug: K-CAB tab. with water; One time dose of K-CAB tab. taken with water; Other Names: K-CAB tab.
EXPERIMENTAL: Group 5	Drug: IN-C004 with water; One time dose of IN-C004 taken with water; Other Names: IN-C004; Drug: IN-C004 without water; One time dose of IN-C004 taken without water; Other Names: IN-C004; Drug: K-CAB tab. with water; One time dose of K-CAB tab. taken with water; Other Names: K-CAB tab.
EXPERIMENTAL: Group 6	Drug: IN-C004 with water; One time dose of IN-C004 taken with water; Other Names: IN-C004; Drug: IN-C004 without water; One time dose of IN-C004 taken without water; Other Names: IN-C004; Drug: K-CAB tab. with water; One time dose of K-CAB tab. taken with water; Other Names: K-CAB tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of tegoprazan	Area under the plasma concentration-time curve of tegoprazan	pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Cmax of tegoprazan	Maximum Plasma Concentration at Steady State of tegoprazan	pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
AUCt of tegoprazan metabolite M1	Area under the plasma concentration-time curve of tegoprazan metabolite M1	pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour
Cmax of tegoprazan metabolite M1	Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1	pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours

Collaborators and Investigators

• Sponsor: HK inno.N Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2021
• Primary Completion (ACTUAL): February 5, 2021
• Study Completion (ACTUAL): February 15, 2021

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IN_KOD_102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No