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

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04654078
Collaborator
(none)
48
Enrollment
1
Location
6
Arms
28
Actual Duration (Days)
52.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: IN-C004 with water
  • Drug: IN-C004 without water
  • Drug: K-CAB tab. with water
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers
Actual Study Start Date :
Jan 18, 2021
Actual Primary Completion Date :
Feb 5, 2021
Actual Study Completion Date :
Feb 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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

    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

    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

    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

    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

    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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonbuk National University Hospital Jeonju Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: Min-Gul Kim, Chonbuk National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT04654078
    Other Study ID Numbers:
    • IN_KOD_102
    First Posted:
    Dec 4, 2020
    Last Update Posted:
    Mar 29, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 29, 2021