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COMPLETEDPHASE1

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

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

NCT05086107•BioVersys AG

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects who are able to understand and follow instructions during the study.
•2. Subjects who signed informed consent.
•3. 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
•* female subjects with documented premature ovarian failure
•4. Weight within a BMI range of 19.0-35.0 kg/m2, range limits inclusive.
•5. Having had no febrile or infectious illness for at least 7 days prior to dosing.
•6. The subject will be available to complete the study.
+14 more criteria

Exclusion Criteria

•1. Unwilling or unable to give informed consent.
•2. As a result of the medical screening process, the study physician considered the subject unfit for the study.
•3. Pregnant or lactating women or men with female partners who are lactating or are pregnant.
•4. 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.
•5. History of antibiotic-associated diarrhoea within one year.
•6. 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.
•7. 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.
•8. A positive screening serology test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)-1 and / or 2.
•9. Positive drugs-of-abuse or alcohol screen.
•10. History of epilepsy, other neurological disorders, or neuropsychiatric con-ditions.
+22 more criteria

Locations (1)

CRU Hungary Kft., Early Phase Unit

Miskolc, Hungary

Key Dates

Start Date

October 8, 2021

Primary Completion Date

May 30, 2022

Completion Date

January 16, 2023

Last Updated

January 18, 2023

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

BV100

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure