Healthy Male Volunteers, Pharmacodynamics, Pharmacokinetics
Conditions
Brief summary
A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects
Detailed description
* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males. * To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males. * To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.
Interventions
DRUGTegoprazan (C1)
Tegoprazan QD, oral administration. Treatment A
DRUGTreatment C: Tegoprazan (C1)
Tegoprazan BID, oral administration
DRUGTegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 1
DRUGEsomeprazole (C2)
Esomeprazole QD, oral administration, for 7 days. Group 3
DRUGTegoprazan (C3)
Tegoprazan QD, oral administration
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Cohort 1: crossover Cohort 2: parallel Cohort 3: single group
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum gastrin concentration | up to 7 days | Serum gastrin concentration |
| Gastric pH | up to 7 days | Gastric pH |
| AUC(0-24h) of tegoprazan | up to 7 days | Area Under the Curve(0-24h) of tegoprazan |
| Cmax of tegoprazan | up to 7 days | Maximum Plasma Concentration of tegoprazan |
Countries
South Korea
Contacts
Primary ContactIn Jin Jang, MD, PhD
Backup ContactMu Seong Ban, MD
Outcome results
None listed