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

IlDong Pharmaceutical Co Ltd0 sites40 target enrollmentFebruary 13, 2020

ConditionsRenal Impairment

InterventionsBesifovir Dipivoxil Maleate

DrugsBesifovir Dipivoxil Maleate

Overview

Phase: Phase 1
Intervention: Besifovir Dipivoxil Maleate
Conditions: Renal Impairment
Sponsor: IlDong Pharmaceutical Co Ltd
Enrollment: 40
Primary Endpoint: Plasma pharmacokinetics (PK) profiles of LB80331: Cmax
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 13, 2020

End Date

April 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IlDong Pharmaceutical Co Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All Individuals:
•Have no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
•Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form
•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.

Exclusion Criteria

•Medical history
•Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hepatic, hematologic, neurologic, thyroid or any other medical illness or psychiatric disorder, as determined by the Investigator
•A person with a history of chronic hepatitis B
•A person with a history of gastrointestinal disorders (ex. Crohn's disease, ulcerative colitis, etc.) or surgery (except for simple appendectomy or herniotomy) that may affect the absorption of the investigational product.
•A person who shows the following in the diagnostic test during the screening period.
•Positive screening test for Hepatitis B Virus surface Antigen (HBs-Ag), human immunodeficiency virus (HIV) test, hepatitis C test, Venereal Disease Research Laboratory (VDRL) test
•Clinically significant abnormal ECG findings.
•Aspartate aminotransferase (AST) and aminotransferase (ALT) values exceed the upper limit of normal range (ULN) by more than 2 times.
•Total Bilirubin, Gamma-Glutamyl Transpeptidase (γ-GTP) \> 1.5 X ULN, Creatine Phosphokinase (CK) \> 2 X ULN
•Clinically significant laboratory abnormalities or abnormalities which are deemed to interfere with the ability to interpret study data.