Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT05684718
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100
Sponsor:
BioVersys AG
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: