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Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects

Sponsor
HK inno.N Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03863938
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
3
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers

Condition or Disease Intervention/Treatment Phase
  • Drug: Tegoprazan 50mg
 Phase 1

Detailed Description

Primary Outcome Measure:

  1. AUClast and Cmax of tegaprazan

  2. Gastric pH

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects
Actual Study Start Date :
Mar 27, 2019
Actual Primary Completion Date :
Apr 26, 2019
Actual Study Completion Date :
Jun 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tegoprazan 50mg under fasting condition

Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day

Drug: Tegoprazan 50mg
K-CAB
Other Names:
  • Tegoprazan 50mg tablet

    		•
    Experimental: Tegoprazan 50mg before the meal

    Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day

    Drug: Tegoprazan 50mg
    K-CAB
    Other Names:
  • Tegoprazan 50mg tablet

    		•
    Experimental: Tegoprazan 50mg after the meal

    Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day

    Drug: Tegoprazan 50mg
    K-CAB
    Other Names:
  • Tegoprazan 50mg tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AUClast of tegaprazan [Pre-dose(0 hour) and up to 48 hours in each period]

      Area under the plasma concentration versus time curve of tegoprazan

    2. Cmax of tegaprazan [Pre-dose(0 hour) and up to 48 hours in each period]

      Peak Plasma Concentration of tegoprazan

    3. Gastric pH [Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period]

      Gastric pH

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy adult males aged ≥ 19 years and ≤ 50 years

    • Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

    • Helicobacter pylori negative

    Exclusion Criteria:

    • Presence or history of clinically significant diseases

    • Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)

    • Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity

    • Serologic test positive

    • Abnormal obstacle to insertion and maintenance of pH meter catheter

    • History of drug abuse

    • Excessive caffeine intake or persistent alcohol intake

    • Not use of a medically acceptable method of contraception

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital, Clinical Trial Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • HK inno.N Corporation

    Investigators

    • Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital, Dept. of Clinical Pharmacology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HK inno.N Corporation
    ClinicalTrials.gov Identifier:
    NCT03863938
    Other Study ID Numbers:
    • CJ_APA_112
    First Posted:
    Mar 5, 2019
    Last Update Posted:
    Aug 22, 2019
    Last Verified:
    Aug 1, 2019
    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 Aug 22, 2019