An Experimental Study of Belzutifan Impact on Catecholamine Metabolism

Summary

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.

Eligibility

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) ≤6 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

Conditions6

Interventions1

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