A Phase 1 Study to Evaluate Safety, Tolerability, and PD of Tegoprazan on Healthy Male Volunteers

Not Applicable

Recruiting

• Conditions: Diseases of the digestive system

• Registration Number: KCT0002701
• Lead Sponsor: CJ Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 16

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric pH;Serum gastrin concentration

Secondary Outcome Measures

Name	Time	Method
Pharmacogenomics