PRA Hungary Ltd.
Budapest, 1077, Hungary
NCT Number: NCT05613036
This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful or no treatment exists can take part. This study tests a medicine called BI 907828. BI 907828 is a so-called p53-MDM2 antagonist that is being developed to treat cancer.
The purpose of the study is to find out how BI 907828 is processed in the body. In the first 3 weeks, participants therefore get a single dose of BI 907828 in a labelled form. The first participants take BI 907828 as a liquid. This is to find out how much BI 907828 is taken up in the body when it is taken by mouth. Participants who join the study later get BI 907828 as an infusion into a vein in a labelled form and take BI 907828 as a normal tablet. This is to find out how long BI 907828 stays in the blood. After the first 3 weeks, all participants take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can tolerate it.
During the study, participants visit the study site regularly. Some of the study visits include staying overnight. At the beginning, some of the participants stay at the study site for 15 nights. The doctors also regularly check participants' health and take note of any unwanted effects.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Budapest, 1077, Hungary
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
*Non-childbearing potential is defined as permanently sterile or post-menopausal. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilization. Postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L or 40 IU/L and estradiol below 30 ng/L or 110.13 pmol/L is confirmatory) without an alternative medical cause.
Exclusion criteria
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)
BI 907828
Other names: Brigimadlin
Time frame: up to 36 days
Time frame: up to 36 days
Time frame: up to 15 days
Time frame: up to 15 days
Time frame: up to 36 days
Time frame: up to 36 days
Time frame: up to 15 days
Boehringer Ingelheim
Industry
An Open-label, Non-randomized Phase I Investigation of Human ADME (Absorption, Distribution, Metabolism and Excretion) and Absolute Oral Bioavailability of BI 907828 in Patients With Advanced 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.
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