A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: BI 907828; Drug: Rifampicin; Drug: Itraconazole

• Registration Number: NCT05372367
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-12
• Study Start: 2022-08-11
• Primary Completion: 2024-07-17
• Study Completion: 2025-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2: CYP3A4 inhibitor	BI 907828	-
Group 1: OATP1B1/B3 inhibitor	Rifampicin	-
Group 1: OATP1B1/B3 inhibitor	BI 907828	-
Group 2: CYP3A4 inhibitor	Itraconazole	-

Primary Outcome Measures

Name	Time	Method
Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 to 24 hours (AUC 0-24)	up to 24 hours
Group 2: Maximum measured concentrations of BI 907828 in plasma (C max)	up to 15 days
Group 1: Maximum measured concentrations of BI 907828 in plasma (C max)	up to 15 days
Group 2: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	up to 15 days

Secondary Outcome Measures

Name	Time	Method
Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 15 days
Group 2: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	up to 15 days
Group 1: Area under the concentration-time curve of BI 907828 in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz)	up to 15 days

Trial Locations

Locations (7)

Hospital Quiron. I.C.U.; 🇪🇸 Barcelona, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

CIO Clara Campal; 🇪🇸 Madrid, Spain

Hospital Quirónsalud Madrid; 🇪🇸 Madrid, Spain

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Brussels - UNIV Saint-Luc; 🇧🇪 Bruxelles, Belgium

Wilrijk - HOSP GZA (St-Augustinus); 🇧🇪 Wilrijk, Belgium