Renal ImpairmentPhase 1NCT05086107

Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment

A Phase 1 study testing BV100 in people with Renal Impairment, run by BioVersys AG at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment after single intravenous (IV) infusion of BV100 Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: BV100
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteHungary
Study dates: 8 Oct 2021to 16 Jan 2023
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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects who are able to understand and follow instructions during the study.
Subjects who signed informed consent.
Male subjects ≥18 and ≤75 years of age; female subjects ≥18 and ≤75 years of age of non-childbearing potential, defined as follows:
female subjects 50 years of age or older, in menopause for 24 consecutive months, and not receiving any hormone replacement therapy within 24 months prior to inclusion into the study
female subjects who underwent surgical sterilization
female subjects who underwent hysterectomy

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female subjects with documented premature ovarian failure
Weight within a BMI range of 19.0-35.0 kg/m2, range limits inclusive.
Having had no febrile or infectious illness for at least 7 days prior to dosing.
The subject will be available to complete the study.
The subject commits to comply with the restrictions and requirements of the protocol and, in the opinion of the study physician, will be able to complete the study.
Control volunteers with normal renal function, in addition to criteria of "All subjects":
Estimated glomerular filtration rate (eGFR) according to MDRD:
≥90 mL/min (normal renal function)
Control subjects have to be in good health or in stable condition, in the opin-ion of the study physician, as determined by medical history, ECG, vital signs, physical examination, and clinical laboratory tests. Subjects having chronic conditions should have an onset of at least 3 months prior to Screening, clini-cally stable, and well-controlled.
Renally impaired patient volunteers, in addition to criteria of "All subjects":
Estimated glomerular filtration rate (eGFR) according to MDRD:
60-89 mL/min (mild renal impairment)
30-59 mL/min (moderate renal impairment)
15-29 mL/min (severe renal impairment)
<15 mL/min (requiring dialysis)
Stable renal impairment, defined as no clinically significant change in dis-ease status within 2 weeks from Screening, as judged by the Investigator.
Subjects with systolic blood pressure ≥ 90 mmHg and diastolic blood pressure ≥ 50 mmHg.
Patients with chronic diseases / conditions other than renal impairment can be included, provided that these diseases / conditions are stable, well-controlled, and do not interfere with the study objectives or the subject's over-all safety, as judged by the Investigator.

Who cannot join

Unwilling or unable to give informed consent.
As a result of the medical screening process, the study physician considered the subject unfit for the study.
Pregnant or lactating women or men with female partners who are lactating or are pregnant.
Known or suspected history of hypersensitivity to rifabutin or excipients or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin; history of allergic reactions leading to hospitalisation or any other allergic con-ditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the Investigator considers may affect the safety of the subject and / or the outcome of the study.
History of antibiotic-associated diarrhoea within one year.
Subjects with significant ECG abnormalities (history, or evidence of sec-ond-degree heart block of Mobitz type II, third degree heart block, or any ab-normality considered relevant by the Investigator), QTcF > 460 ms, PR > 200 ms, or QRS duration > 120 ms.

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History of symptomatic, chronic or recurrent infection (e.g. nausea, vomit-ing, diarrhoea, infection with fever) or any viral, bacterial, fungal or parasitic infection within 30 days prior to admission to the clinical unit.
A positive screening serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)-1 and / or 2.
Positive drugs-of-abuse or alcohol screen.
History of epilepsy, other neurological disorders, or neuropsychiatric con-ditions.
History of seizures.
Subjects having used megadose vitamins (i.e. 20 to 600 times the recom-mended daily supplement dose) within 7 days prior to dosing, unless in the opinion of the study physician the medication does not interfere with the study procedures or compromise safety
Volunteers who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes, utilized within 30 days of IMP administration.
Regular use within 3 months of IMP administration of a CYP3A enzyme modifier - any inhibitor, moderate or strong inducer, and sensitive or moder-ately sensitive substrate, as listed in Section 11.3 'Prohibited concomitant med-ications'.
Volunteers who have participated in a clinical study involving administra-tion of an investigational drug within the following time period prior to the dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Volunteers who consume more than 21 units of alcohol per week, or who have a significant history of alcohol abuse (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 30 mL of 40% of alcohol by volume distilled spirits).
Excessive consumption of caffeine- or xanthine-containing food or bever-ages (> 5 cups of coffee a day or equivalent), or inability to stop consuming from 48 hours prior to study treatment administration.
Subjects who smoke more than 10 cigarettes a day.
Any use of drugs-of-abuse or alcohol abuse within 2 years prior to the first admission to the clinical unit.
Inability to understand or communicate reliably with the Investigator or considered by the Investigator to be unable to or unlikely to co-operate with the requirements of the study.
Any other conditions or factors which in the opinion of the Investigator may interfere with study conduct. Failure to satisfy the Investigator of fitness to participate for any other reason.
Any significant blood loss, donation of one unit (450 mL) of blood or more, or receipt of transfusion of any blood or blood products within 60 days, or plasma donation within 7 days prior to the first admission to the clinical study site.
Volunteers who are employees or immediate family members of the study site or Sponsor.
Control volunteers with normal renal function, in addition to criteria of "All subjects":
Supine systolic blood pressure > 150 mmHg or < 90 mmHg, or diastolic blood pressure > 100 mmHg or < 50 mmHg at Screening or on Day 1, prior to dosing (any abnormal blood pressure results may be repeated arbitrarily, and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion). Pulse rate > 100 or < 50 beats per minute at Screening or on Day 1, prior to dosing.
Screening laboratory values should not exceed 1.5 x ULN, and the eventu-al deviation should be deemed as being clinically non-significant. Any abnor-mal value of these parameters may be repeated arbitrarily, and if the repeated result is within the allowed range, it is not considered to have met the exclusion criterion.
Volunteers who have received any new prescribed systemic or topical medication within 4 weeks of the first dose administration.
Renally impaired patient volunteers, in addition to criteria of "All subjects":
Acute renal failure (as judged by the Investigator).
History of kidney transplant regardless of functionality.
History of nephrectomy.
Start of any new medication or any changes to current dosages within 14 days prior to study drug administration.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

CRU Hungary Kft., Early Phase Unit
Miskolc, H-3529

Other trials in Hungary

About this study

Official title: An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of BV100 Administered as Single Intravenous In-fusion to Subjects With Renal Impairment

To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment after single intravenous (IV) infusion of BV100

Read the detailed description

To investigate the pharmacokinetics (PK) of rifabutin and excipient in subjects with renal impairment after single intravenous (IV) infusion of BV10=. In addition to investigate the safety and tolerability of BV100 in subjects with renal impairment and to investigate the PK of 25-acyl-rifabutin metabolite in subjects with renal impairment after single intravenous (IV) infusion of BV100

Conditions: Renal Impairment
Being tested: BV100
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BV100Drug
Also called Rifabutin for Infusion
Rifabutin for infusion

Study groups in NCT05086107
Study group	Role	What they receive
Group 1	Experimental	subjects with mild renal impairment (eGFR: 60 to 89 mL/min) Receives: Drug: BV100
Group 2	Experimental	subjects with moderate renal impairment (eGFRr: 30 to 59 mL/min) Receives: Drug: BV100
Group 3	Experimental	subjects with severe renal impairment (eGFR: 15-29 mL/min) Receives: Drug: BV100
Group 4	Experimental	subjects with normal renal function (eGFR: ≥ 90 mL/min) Receives: Drug: BV100
Group 5	Experimental	subjects with end stage renal disease (ESRD) eGFR: <15 mL/min requiring dialysis (with BV100 dosing and PK during the dialysis-free interval) Receives: Drug: BV100
Group 6	Experimental	subjects with ESRD (eGFRr: <15 mL/min) requiring dialysis (with BV100 dosing and PK on the day of dialysis) Receives: Drug: BV100

What is being measured

The primary outcome is the main question the study is designed to answer.

To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment
Area under the plasma concentration versus time curve (AUC)
Measured: 96 hours
To characterize the single dose pharmacokinetic profile of rifabutin
Peak Plasma Concentration (Cmax)
Measured: 96 hours

Secondary outcomes (2)

To investigate the safety and tolerability of single intravenous ascending doses of BV100 assessed by the nature, occurrence, and severity of treatment-emergent adverse events
Safety and Tolerability
Measured: 7 days
To determine the plasma concentration of the main metabolite 25-O-Desacetyl-Rifabutin in plasma in subjects with renal impairment
Pharmacokinetics
Measured: 96 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202116 Jan 2023

First posted20 Oct 2021
Study start8 Oct 2021
Primary completion30 May 2022
Study completion16 Jan 2023

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: Basic science
Allocation: Not applicable
Intervention model: Sequential
Model description: BV100 administered as a single intravenous infusion to subjects with varying degree of renal impairment and control volunteers with normal renal function.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05086107
Sponsor's protocol ID: BV100-003
Status last verified: Jun 2022
First submitted: 8 Oct 2021
Last updated: 18 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of BV100 Administered as Single Intravenous In-fusion to Subjects With Renal Impairment
ClinicalTrials.gov ID: NCT05086107
Acronym / sponsor ID: BV100-003
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: BioVersys AGIndustry (pharma, biotech, devices)
Collaborators: Clinical Research Units Hungary
Study start: 8 Oct 2021 (actual)
Primary completion: 30 May 2022 (actual)
Study completion: 16 Jan 2023 (actual)
First posted: 20 Oct 2021 (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.

To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment after single intravenous (IV) infusion of BV100

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6
Model description: BV100 administered as a single intravenous infusion to subjects with varying degree of renal impairment and control volunteers with normal renal function.

Arm	Type	Receives
Group 1	Experimental	Drug: BV100subjects with mild renal impairment (eGFR: 60 to 89 mL/min)
Group 2	Experimental	Drug: BV100subjects with moderate renal impairment (eGFRr: 30 to 59 mL/min)
Group 3	Experimental	Drug: BV100subjects with severe renal impairment (eGFR: 15-29 mL/min)
Group 4	Experimental	Drug: BV100subjects with normal renal function (eGFR: ≥ 90 mL/min)
Group 5	Experimental	Drug: BV100subjects with end stage renal disease (ESRD) eGFR: <15 mL/min requiring dialysis (with BV100 dosing and PK during the dialysis-free interval)
Group 6	Experimental	Drug: BV100subjects with ESRD (eGFRr: <15 mL/min) requiring dialysis (with BV100 dosing and PK on the day of dialysis)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Subjects who are able to understand and follow instructions during the study.
Subjects who signed informed consent.
Male subjects ≥18 and ≤75 years of age; female subjects ≥18 and ≤75 years of age of non-childbearing potential, defined as follows:
Weight within a BMI range of 19.0-35.0 kg/m2, range limits inclusive.
Having had no febrile or infectious illness for at least 7 days prior to dosing.

Key exclusion criteria (32 listed)

Unwilling or unable to give informed consent.
As a result of the medical screening process, the study physician considered the subject unfit for the study.
Pregnant or lactating women or men with female partners who are lactating or are pregnant.
Known or suspected history of hypersensitivity to rifabutin or excipients or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin; history of allergic reactions leading to hospitalisation or any other allergic con-ditions (including drug allergies, asthma, eczema, anaphylactic reactions but excluding untreated, asymptomatic, seasonal allergies) which the Investigator considers may affect the safety of the subject and / or the outcome of the study.
History of antibiotic-associated diarrhoea within one year.

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
BV100Also: Rifabutin for InfusionRifabutin for infusion	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment
Time frame: 96 hours
Area under the plasma concentration versus time curve (AUC)
To characterize the single dose pharmacokinetic profile of rifabutin
Time frame: 96 hours
Peak Plasma Concentration (Cmax)

2 secondary outcomes

To investigate the safety and tolerability of single intravenous ascending doses of BV100 assessed by the nature, occurrence, and severity of treatment-emergent adverse events
Time frame: 7 days
To determine the plasma concentration of the main metabolite 25-O-Desacetyl-Rifabutin in plasma in subjects with renal impairment
Time frame: 96 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
Individual participant dataSharing planned: No

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BV100 in people with Renal Impairment, run by BioVersys AG at 1 site in Hungary.

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 24 inclusion and 32 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To investigate the pharmacokinetics (PK) of rifabutin in subjects with renal impairment (time frame: 96 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?

On the ClinicalTrials.gov record for NCT05086107.

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 18 Jan 2023.