Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT02457351
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2015-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of Roniciclib in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-05
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:
To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients.
To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients
To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: