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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002887

Enrollment

Registered

2018-05-21

Start date

2018-05-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Cohort 1 - Tegoprazan Treatment A, QD, oral administration - Tegoprazan Treatment B, QD, oral administration - Tegoprazan Treatment C, BID, oral administration Cohort 2 - Tegoprazan Group 1

Eligibility

Sex/Gender

Male

Inclusion 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

Exclusion criteria

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
Pharmacokinetics;PD (gastric pH);PD (serum gastrin concentration)	—

Secondary

Measure	Time frame
Pharmacogenomics	—

Countries

Korea, Republic of

Contacts

Public ContactIn Jin Jang

Seoul National University Hospital

injin.jang@gmail.com+82-2-740-8290

Outcome results