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

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378284
• Other study ID #: CJ_APA_108
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2017
• Last updated: March 28, 2018
• Start date: December 10, 2017
• Est. completion date: January 16, 2018

Study information

• Verified date: December 2017
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

• To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.

• To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 16, 2018
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Volunteers
• Pharmacodynamics

Intervention

Drug:
• Tegoprazan
Tegoprazan QD for 7 days
• Revaprazan
Revaprazan QD for 7 days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric pH	Gastric pH	up to 7 days
Primary	Serum gastrin concentration	Serum gastrin concentration	up to 9 days