NCT05086107

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (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 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

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	BV100	Rifabutin for infusion

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-05-30
• Completion: 2023-01-16
• First posted: 2021-10-20
• Last updated: 2023-01-18

Locations

1 site across 1 country: Hungary