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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
BioVersys AG·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Bacterial Infections
Drug/Device/Intervention
BV100 (300 mg)
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
BioVersys AG
Location
Kistarcsa, Hungary
Timeline & enrollment
Phase
Phase 1
Start date
Feb 01, 2023
End date
Dec 01, 2023
Enrollment
16 participants
Primary outcome

To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous rifabutin,To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous rifabutin,To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous 25-O-deacetyl-rifabutin,To evaluate the effect of repeated doses of itraconazole on the pharmacokinetics of intravenous 25-O-deacetyl-rifabutin

Summary

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

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsOther bacterial intestinal infectionsOther bacterial diseasesOther specified bacterial intestinal infections
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05684718
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05684718 through Pure Global AI's free database. This Phase 1 trial is sponsored by BioVersys AG and is currently Not yet recruiting. The study focuses on Bacterial Infections. Target enrollment is 16 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.