Pharmacokinetics of Besifovir in Adults With Normal and Impaired Renal Function

NCT04249908 | Unknown Phase 1

• 1 other identifier: ID-BVCL-103
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Safety profile of Besifovir as measured by incidence of adverse events and laboratory abnormalities

  Up to 16 days

Study Arms (4)

Healthy Subjects

ACTIVE COMPARATOR

Drug: Besifovir Dipivoxil Maleate

Mild Renal Impairment (RI)

EXPERIMENTAL

Drug: Besifovir Dipivoxil Maleate

Moderate RI

EXPERIMENTAL

Drug: Besifovir Dipivoxil Maleate

Severe RI

EXPERIMENTAL

Drug: Besifovir Dipivoxil Maleate

Interventions

Besifovir Dipivoxil Maleate DRUG

Besifovir 150 mg q.d.

Healthy Subjects; Mild Renal Impairment (RI); Moderate RI; Severe RI

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• A healthy adult who is at least 19 years old at the time of the screening visit.
• A person whose BMI is greater than 18 kg/m\^2 and less than 30 kg/m\^2 at the time of the screening visit.

You may not qualify if:

• 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.
• 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
• A person who has been administered with the investigational product or a bioequivalence study drug in another clinical trial within 180 days of the screening visit.
• Other criteria
• A woman whose urine human chorionic gonadotropin (hCG) test results were positive and who is pregnant or breastfeeding.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Kim Min Jung

CONTACT

8225263179; mjkim90@ildong.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: February 13, 2020
• Primary Completion: September 1, 2020
• Study Completion: April 1, 2021
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share