NCT05537142

A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment

A Phase I, Open-label, Single-center, Single-dose, Parallel Group Study to Evaluate the Pharmacokinetics of BV100 in Participants with Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Healthy Control Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: BioVersys AG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BV100	Rifabutin for Infusion

Timeline

• Start date: 2022-09-02
• Primary completion: 2024-07-30
• Completion: 2024-10-30
• First posted: 2022-09-13
• Last updated: 2025-01-14

Locations

1 site across 1 country: Hungary