A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy
- Hepatic Impairment
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 70 years
- Gender
- Both males and females
Description
[Pharmacokinetic Assessment] Measurements - Tegoprazan and desmethyl tegoprazan (M1) in blood and urine Endpoints Primary endpoints: AUClast and Cmax of tegoprazan and M1 Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1 [Safety Assessment] Adverse ev...
[Pharmacokinetic Assessment] Measurements - Tegoprazan and desmethyl tegoprazan (M1) in blood and urine Endpoints Primary endpoints: AUClast and Cmax of tegoprazan and M1 Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1 [Safety Assessment] Adverse events (AEs) Clinical laboratory tests Vital sign Physical examination Electrocardiogram (ECG)
Tracking Information
- NCT #
- NCT04494269
- Collaborators
- Not Provided
- Investigators
- Study Chair: Jung-Ryul Kim, MD, PhD Samsung Medical Center Principal Investigator: Yang-Won Min, MD, PhD Samsung Medical Center Principal Investigator: Dong-Seong Shin, MD, PhD Gachon University Gil Medical Center Principal Investigator: Eon-Hye Kim, MD, PhD CHA Bundang Medical Center
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