Renal ImpairmentPhase 1NCT04249908
Pharmacokinetics of Besifovir in Adults With Normal and Impaired Renal Function
A Phase 1 study testing Besifovir Dipivoxil Maleate in people with Renal Impairment, run by IlDong Pharmaceutical Co Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Besifovir Dipivoxil Maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2020to Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- 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
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- 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.
- A person who has donated partial or full amount of blood within 60 days of the screening visit, who has given blood through apheresis within 28 days, or who has been transfused within 28 days.
- History of regular alcohol intake > 21 units per week of alcohol before 28 dyas or unwilling to abstain from alcohol for study period before the start of admission until the final Completion Visit assessments.
- A person who has smoked excessively within 28 days of the screening visit or whose (> 10 cigarettes/day) or◦ who can't quit smoking during the trial
- Consumption of caffeine products within 28 days (caffeine drink > 7 glass/day) who can't abstain from caffeine products during the trial
- Consumption of any grapefruit juice within 48 hours before administration of investigational product or subjects who can't abstain from grapefruit juice during the trial
- Fertile subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 2 weeks after the administration of investigational product.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subjects who are considered to be unacceptable in this study under the opinion of the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Renal Impairment
- Being tested
- Besifovir Dipivoxil Maleate
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Besifovir Dipivoxil MaleateDrug
Besifovir 150 mg q.d.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Not described Receives: Drug: Besifovir Dipivoxil Maleate |
| Mild Renal Impairment (RI) | Experimental | Not described Receives: Drug: Besifovir Dipivoxil Maleate |
| Moderate RI | Experimental | Not described Receives: Drug: Besifovir Dipivoxil Maleate |
| Severe RI | Experimental | Not described Receives: Drug: Besifovir Dipivoxil Maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Review of adverse events and safety labs
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start13 Feb 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249908
- Sponsor's protocol ID
- ID-BVCL-103
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04249908
- Acronym / sponsor ID
- ID-BVCL-103
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Besifovir Dipivoxil MaleateBesifovir 150 mg q.d. | Drug | Healthy Subjects, Mild Renal Impairment (RI), Moderate RI, Severe RI |
Primary outcome
Plasma pharmacokinetics (PK) profiles of LB80331: Area under the plasma concentration-time curve (AUC)_0-t
Time frame: 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
Time frame: 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
1 secondary outcome
Safety profile of Besifovir as measured by incidence of adverse events and laboratory abnormalities
Time frame: Up to 16 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Besifovir Dipivoxil Maleate in people with Renal Impairment, run by IlDong Pharmaceutical Co Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Min Jung (8225263179, mjkim90@ildong.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma pharmacokinetics (PK) profiles of LB80331: Area under the plasma concentration-time curve (AUC)_0-t (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.