Food-Effect on PK and PD of Single Oral Dose of Tegoprazan in Healthy Male Subjects
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
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedStudy Start
First participant enrolled
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2019
CompletedAugust 22, 2019
August 1, 2019
1 month
February 28, 2019
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
AUClast of tegaprazan
Area under the plasma concentration versus time curve of tegoprazan
Pre-dose(0 hour) and up to 48 hours in each period
Cmax of tegaprazan
Peak Plasma Concentration of tegoprazan
Pre-dose(0 hour) and up to 48 hours in each period
Gastric pH
Gastric pH
Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Study Arms (3)
Tegoprazan 50mg under fasting condition
EXPERIMENTALTreatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day
Tegoprazan 50mg before the meal
EXPERIMENTALTreatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day
Tegoprazan 50mg after the meal
EXPERIMENTALTreatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day
Interventions
K-CAB
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital, Clinical Trial Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In-Jin Jang, MD, PhD
Seoul National University Hospital, Dept. of Clinical Pharmacology
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2019
First Posted
March 5, 2019
Study Start
March 27, 2019
Primary Completion
April 26, 2019
Study Completion
June 25, 2019
Last Updated
August 22, 2019
Record last verified: 2019-08