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โ† Trials
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An Experimental Study of Belzutifan Impact on Catecholamine Metabolism

RecruitingPhase 2Ages any - anyAllCambridge University Hospitals NHS Foundation Truโ€ฆ
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In plain words

What the trial is, and whether it could suit you

To investigate the impact of a medication called Belzutifan on the production and subsequent metabolism of adrenaline and noradrenaline collectively termed 'catecholamines'. The study aims to identify changes in the production and metabolism of catecholamines by measuring the substance which starts the chain of catecholamine metabolism called tyrosine in patients before, during and after 5 days of taking Belzutifan 120mg daily.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adult patients \> 18 years * Patients must have a biochemically confirmed diagnosis of a phaeochromocytoma or paraganglioma using plasma metanephrines or 24- hour urinary metanephrines and plasma or urinary metanephrines should be at least 1.5 times the upper limit of the normal reference range. * Female patients of child-bearing potential must have a negative serum pregnancy test result within 3 days before first administration of study drug * Able to provide informed consent Exclusion Criteria: * Has hypoxia, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen. * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass graft surgery (CABG) โ‰ค6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted. * Has a co-existing malignancy (in addition to PPGL) * Has a Hb \< 100g/dL * Is on medications which may interfere with belzutifan pharmacokinetics and that cannot be stopped for the duration of the study and for 7 days after the study period (everolimus, omeprazole, esomeprazole, Fluconazole, fluoxetine, Voriconazole, Sirolimus) * Has a known diagnosis of HIV, hepatitis B or hepatitis C
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What it tests

  • Belzutifan
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Where

1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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