A Phase 1 Study of Tegoprazan on Healthy Male Volunteers
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
1 other identifier
interventional
44
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
May 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedMay 21, 2018
May 1, 2018
3 months
May 8, 2018
May 18, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
AUC(0-24h) of tegoprazan
Area Under the Curve(0-24h) of tegoprazan
up to 7 days
Cmax of tegoprazan
Maximum Plasma Concentration of tegoprazan
up to 7 days
Gastric pH
Gastric pH
up to 7 days
Serum gastrin concentration
Serum gastrin concentration
up to 7 days
Study Arms (7)
Treatment A: Tegoprazan (C1)
EXPERIMENTALTegoprazan QD, oral administration
Treatment B: Tegoprazan (C1)
EXPERIMENTALTegoprazan QD, oral administration
Treatment C: Tegoprazan (C1)
EXPERIMENTALTegoprazan BID, oral administration
Group 1: Tegoprazan (C2)
EXPERIMENTALTegoprazan QD, oral administration, for 7 days
Group 2: Tegoprazan (C2)
EXPERIMENTALTegoprazan QD, oral administration, for 7 days
Group 3: Esomeprazole (C2)
ACTIVE COMPARATOREsomeprazole QD, oral administration, for 7 days
Tegoprazan (C3)
EXPERIMENTALTegoprazan QD, oral administration
Interventions
Esomeprazole QD, oral administration, for 7 days. Group 3
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2018
First Posted
May 21, 2018
Study Start
May 1, 2018
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
May 21, 2018
Record last verified: 2018-05