A Phase 1 Study to Evaluate Safety/Tolerability and PD/PK of Tegoprazan on Healthy Male Volunteers
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002887
- Lead Sponsor
- CJ Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 44
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
- 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics;PD (gastric pH);PD (serum gastrin concentration)
- Secondary Outcome Measures
Name Time Method Pharmacogenomics