NCT05684718

To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100

A Phase 1 Single Center Open-label, Non-randomized, Fixed Sequence Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of BV100 When Administered Alone and With Itraconazole

• 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

Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of BV100 in healthy volunteers.

Detailed description

This is an open-label, fixed-sequence Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of rifabutin, 25 O deacetyl-rifabutin and DMI in healthy volunteers.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	BV100 (300 mg)	Intravenous solution
DRUG	Itraconazole 200 mg	Oral solution

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-09-30
• Completion: 2023-10-31
• First posted: 2023-01-13
• Last updated: 2023-11-21

Locations

1 site across 1 country: Hungary