A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530228
• Other study ID #: CJ_APA_109
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2018
• Est. completion date: August 2018

Study information

• Verified date: May 2018
• Source: CJ HealthCare Corporation
• Contact: In Jin Jang, MD, PhD
• Phone: 82-2-2072-1666
• Email: ijjang[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• 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
• Pharmacokinetics

Intervention

Drug:
• Tegoprazan (C1)
Tegoprazan QD, oral administration. Treatment A
• Tegoprazan (C1)
Tegoprazan QD, oral administration. Treatment B
• Treatment C: Tegoprazan (C1)
Tegoprazan BID, oral administration
• Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 1
• Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 2
• Esomeprazole (C2)
Esomeprazole QD, oral administration, for 7 days. Group 3
• Tegoprazan (C3)
Tegoprazan QD, oral administration

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	AUC(0-24h) of tegoprazan	Area Under the Curve(0-24h) of tegoprazan	up to 7 days
Primary	Cmax of tegoprazan	Maximum Plasma Concentration of tegoprazan	up to 7 days
Primary	Gastric pH	Gastric pH	up to 7 days
Primary	Serum gastrin concentration	Serum gastrin concentration	up to 7 days