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

A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002701

Enrollment

Registered

2018-02-23

Start date

2017-12-10

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 : Study drug : Tegoprazan QD for 7 days Comparator drug : Active comparator drug QD for 7 days

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
Gastric pH;Serum gastrin concentration	—

Secondary

Measure	Time frame
Pharmacogenomics	—

Countries

Korea, Republic of

Contacts

Public ContactJung Sungwoo

Seoul National University Hospital

swj4991@gmail.com+82-2-2072-4083

Outcome results