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To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100 - Trial NCT05684718

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.

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NCT05684718
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05684718
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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

Study Focus

Bacterial Infections

BV100 (300 mg)

Interventional

drug

Sponsor & Location

BioVersys AG

Kistarcsa, Hungary

Timeline & Enrollment

Phase 1

Feb 01, 2023

Dec 01, 2023

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, unspecified
Bacterial, viral and other infectious agents
Other bacterial intestinal infections
Other bacterial diseases
Other specified bacterial intestinal infections

Data Source

ClinicalTrials.gov

NCT05684718

Non-Device Trial