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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: IN-C004 with water; Drug: IN-C004 without water; Drug: K-CAB tab. with water

• Registration Number: NCT04654078
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2021-01-18
• Primary Completion: 2021-02-05
• Study Completion: 2021-02-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 6	K-CAB tab. with water	Group 6
Group 1	IN-C004 with water	Group 1
Group 2	IN-C004 with water	Group 2
Group 2	IN-C004 without water	Group 2
Group 5	IN-C004 with water	Group 5
Group 5	IN-C004 without water	Group 5
Group 3	IN-C004 without water	Group 3
Group 4	IN-C004 with water	Group 4
Group 6	IN-C004 with water	Group 6
Group 2	K-CAB tab. with water	Group 2
Group 3	IN-C004 with water	Group 3
Group 1	IN-C004 without water	Group 1
Group 1	K-CAB tab. with water	Group 1
Group 3	K-CAB tab. with water	Group 3
Group 4	IN-C004 without water	Group 4
Group 4	K-CAB tab. with water	Group 4
Group 6	IN-C004 without water	Group 6
Group 5	K-CAB tab. with water	Group 5

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of