BI 907828
DrugBI 907828
Other names: Brigimadlin
NCT Number: NCT05372367
This study is open for adults with advanced cancer (solid tumours). This is a study for people for whom previous treatment was not successful.
This study tests a medicine called BI 907828. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. The purpose of this study is to find out whether the amount of BI 907828 in the blood is influenced by taking an OATP inhibitor or a CYP3 inhibitor. This study uses an OATP inhibitor called rifampicin and a CYP3 inhibitor called itraconazole. In clinical practice, rifampicin is used as an antibiotic. Itraconazole is used to treat fungal infections.
Participants are divided into 2 groups: a rifampicin group and an itraconazole group. Every participant takes BI 907828 as a tablet every 3 weeks. This is called a cycle.
* Rifampicin group: In addition to BI 907828, participants take 1 tablet of rifampicin in the second cycle. * Itraconazole group: In addition to BI 907828, participants take itraconazole tablets for 20 days starting 1 week after the second cycle begins
Participants can stay in the study as long as they benefit from treatment and can tolerate it.
The doctors take blood samples from the participants to compare the amount of BI 907828 in the blood when it is taken alone and when participants also take rifampicin. Doctors also regularly check participants' health and take note of any unwanted effects.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Cliniques Universitaires Saint-Luc, Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Further exclusion criteria apply.
BI 907828
Other names: Brigimadlin
Rifampicin
Itraconazole
Time frame: up to 24 hours
Time frame: up to 15 days
Time frame: up to 15 days
Time frame: up to 15 days
Time frame: up to 15 days
Time frame: up to 15 days
Time frame: up to 15 days
Boehringer Ingelheim
Industry
An Open-label Fixed Sequence Trial to Investigate the Potential Drug-drug Interaction When BI 907828 is Co-administered With an OATP1B1 and/or OATP1B3 Transporter Inhibitor or With a CYP3A4 Inhibitor in Patients With Various Solid Tumours
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01875601
Brain Diseases, Brain Neoplasms
Bethesda, Maryland, United States
View Trial DetailsNCT02379416
Neoplasms, Solid Tumors
Bethesda, Maryland, United States
View Trial DetailsNCT02423057
Neoplasms, Solid Tumors
Bethesda, Maryland, United States
View Trial DetailsNCT05512377
Biliary Tract Cancer, Biliary Tract Diseases
Mobile, Alabama, United States
View Trial Details