A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment
NCT05537142 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2025-01-14
Summary
To investigate the pharmacokinetics (PK) of rifabutin in subjects with hepatic impairment after single intravenous (IV) infusion of BV100
Conditions
- Healthy Participants
Interventions
- DRUG
-
BV100
Rifabutin for Infusion
Sponsors & Collaborators
-
Clinical Research Units Hungary
collaborator OTHER -
BioVersys AG
lead INDUSTRY
Principal Investigators
-
Geza Lakner, MD · Clinical Research Units Hungary
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-02
- Primary Completion
- 2024-07-30
- Completion
- 2024-10-30
Countries
- Hungary
Study Locations
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