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A Non-randomized, Open, Single-dose, Parallel Designed Clinical Study to Evaluate Safety and Pharmacokinetic Characteristics After Oral Administration of Besivo® in Patients With Renal Impairment and Healthy Adult Volunteers
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of Besifovir and its metabolite, LB80331, in participants with normal and impaired renal function
Details
| Lead sponsor | IlDong Pharmaceutical Co Ltd |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 40 |
| Start date | 2020-02-13 |
| Completion | 2021-04 |
Conditions
- Renal Impairment
Interventions
- Besifovir Dipivoxil Maleate
Primary outcomes
- Plasma pharmacokinetics (PK) profiles of LB80331: Area under the plasma concentration-time curve (AUC)_0-t — Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hours
This endpoint will measure the plasma PK profiles of LB80331. PK parameters that will be measured include AUC\_0-t - Plasma pharmacokinetics (PK) profiles of LB80331: Cmax — Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72 hours
This endpoint will measure the plasma PK profiles of LB80331. PK parameters that will be measured include Cmax