Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Active Comparator |
| |
| Mild Renal Impairment (RI) | Experimental |
| |
| Moderate RI | Experimental |
| |
| Severe RI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besifovir Dipivoxil Maleate | Drug | Besifovir 150 mg q.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics (PK) profiles of LB80331: Area under the plasma concentration-time curve (AUC)_0-t | This endpoint will measure the plasma PK profiles of LB80331. PK parameters that will be measured include 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 |
| Plasma pharmacokinetics (PK) profiles of LB80331: Cmax | This endpoint will measure the plasma PK profiles of LB80331. PK parameters that will be measured include 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of Besifovir as measured by incidence of adverse events and laboratory abnormalities | Review of adverse events and safety labs | Up to 16 days |
Not provided
Inclusion Criteria:
All Individuals:
Individuals with mild, moderate, or severe renal impairment must also meet the following additional inclusion criteria to be eligible for participation in this study:
Age of 19 to 65 years at the time of the screening visit.
A person whose body mass index (BMI) is greater than 18 kg/m^2 and less than 27 kg/m^2 at the time of the screening visit.
Individuals with severe renal impairment, estimated Glomerular Filtration Rate (eGFR) must be 15-29 mL/min/1.73m^2 (using the Modification of Diet in Renal Disease (MDRD) method) at the time of the screening visit.
Individuals with moderate renal impairment, eGFR must be 30-59 mL/min/1.73m^2 (using the MDRD method) at the time of the screening visit.
Individuals with mild renal impairment, eGFR must be 60-89 mL/min/1.73m^2 (using the MDRD method) at the time of the screening visit.
Stable renal impairment with no clinically significant changes within 3 months prior to the screening visit.
Individuals with normal renal function must also meet the following additional inclusion criteria to be eligible for participation in this study:
Exclusion Criteria:
Medical history
A person who shows the following in the diagnostic test during the screening period.
A person who has a history of drug abuse or whose urine drug screening test result during the screening period came back positive for abusive drug use.
The contraindication of comedication drugs and diets
Other criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim Min Jung | Contact | 8225263179 | mjkim90@ildong.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |