A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
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To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
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To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
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To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment A: Tegoprazan (C1) Tegoprazan QD, oral administration |
Drug: Tegoprazan (C1)
Tegoprazan QD, oral administration. Treatment A
|
Experimental: Treatment B: Tegoprazan (C1) Tegoprazan QD, oral administration |
Drug: Tegoprazan (C1)
Tegoprazan QD, oral administration. Treatment B
|
Experimental: Treatment C: Tegoprazan (C1) Tegoprazan BID, oral administration |
Drug: Treatment C: Tegoprazan (C1)
Tegoprazan BID, oral administration
|
Experimental: Group 1: Tegoprazan (C2) Tegoprazan QD, oral administration, for 7 days |
Drug: Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 1
|
Experimental: Group 2: Tegoprazan (C2) Tegoprazan QD, oral administration, for 7 days |
Drug: Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days. Group 2
|
Active Comparator: Group 3: Esomeprazole (C2) Esomeprazole QD, oral administration, for 7 days |
Drug: Esomeprazole (C2)
Esomeprazole QD, oral administration, for 7 days. Group 3
|
Experimental: Tegoprazan (C3) Tegoprazan QD, oral administration |
Drug: Tegoprazan (C3)
Tegoprazan QD, oral administration
|
Outcome Measures
Primary Outcome Measures
- AUC(0-24h) of tegoprazan [up to 7 days]
Area Under the Curve(0-24h) of tegoprazan
- Cmax of tegoprazan [up to 7 days]
Maximum Plasma Concentration of tegoprazan
- Gastric pH [up to 7 days]
Gastric pH
- Serum gastrin concentration [up to 7 days]
Serum gastrin concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adult males aged ≥ 19 years and ≤ 50 years
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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:
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Presence or history of clinically significant diseases
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Presence or history of gastrointestinal disorder (gastric ulcer, GERD, - Crohn's disease, etc.)
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Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
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Serologic test positive
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Abnormal obstacle to insertion and maintenance of pH meter catheter
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History of drug abuse
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Excessive caffeine intake or persistent alcohol intake
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Not use of a medically acceptable method of contraception
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- HK inno.N Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CJ_APA_109