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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03863938
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Study Description
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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
Healthy Drug: Tegoprazan 50mg Phase 1

Detailed Description:

Primary Outcome Measure:

  1. AUClast and Cmax of tegaprazan
  2. Gastric pH
Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 27, 2019
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : June 25, 2019
Arms and Interventions
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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 Name: 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 Name: 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 Name: Tegoprazan 50mg tablet


Outcome Measures
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Primary Outcome Measures :
  1. AUClast of tegaprazan [ Time Frame: 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 [ Time Frame: Pre-dose(0 hour) and up to 48 hours in each period ]
    Peak Plasma Concentration of tegoprazan

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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863938


Locations
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Korea, Republic of
Seoul National University Hospital, Clinical Trial Center
Seoul, Korea, Republic of
Sponsors and Collaborators
HK inno.N Corporation
Investigators
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Principal Investigator: In-Jin Jang, MD, PhD Seoul National University Hospital, Dept. of Clinical Pharmacology
More Information
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Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT03863938    
Other Study ID Numbers: CJ_APA_112
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No