NCT05537090

A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants

A Single Center, Open-label, 3-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: BioVersys AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of midazolam and 1-hydroxymidazolam.

Detailed description

A single center, open-label, 3-period fixed-sequence, Phase I clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in healthy volunteers

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BV100	Rifabutin for Infusion
DRUG	Midazolam	Syrup for oral administration

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-07-31
• Completion: 2023-09-30
• First posted: 2022-09-13
• Last updated: 2023-11-21

Locations

1 site across 1 country: Hungary