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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05537142 on ClinicalTrials.gov