A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

HK inno.N

Status and phase: Unknown; Phase 1

Conditions: Pharmacodynamics; Healthy Male Volunteers; Pharmacokinetics

Treatments: Drug: Tegoprazan (C1); Drug: Treatment C: Tegoprazan (C1); Drug: Esomeprazole (C2); Drug: Tegoprazan (C2); Drug: Tegoprazan (C3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03530228

CJ_APA_109

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 estimated patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

44 participants in 7 patient groups

Treatment A: Tegoprazan (C1)

Experimental group

Description:

Tegoprazan QD, oral administration

Treatment:

Drug: Tegoprazan (C1)

Drug: Tegoprazan (C1)

Treatment B: Tegoprazan (C1)

Experimental group

Description:

Tegoprazan QD, oral administration

Treatment:

Drug: Tegoprazan (C1)

Drug: Tegoprazan (C1)

Treatment C: Tegoprazan (C1)

Experimental group

Description:

Tegoprazan BID, oral administration

Treatment:

Drug: Treatment C: Tegoprazan (C1)

Group 1: Tegoprazan (C2)

Experimental group

Description:

Tegoprazan QD, oral administration, for 7 days

Treatment:

Drug: Tegoprazan (C2)

Drug: Tegoprazan (C2)

Group 2: Tegoprazan (C2)

Experimental group

Description:

Tegoprazan QD, oral administration, for 7 days

Treatment:

Drug: Tegoprazan (C2)

Drug: Tegoprazan (C2)

Group 3: Esomeprazole (C2)

Active Comparator group

Description:

Esomeprazole QD, oral administration, for 7 days

Treatment:

Drug: Esomeprazole (C2)

Tegoprazan (C3)

Experimental group

Description:

Tegoprazan QD, oral administration

Treatment:

Drug: Tegoprazan (C3)