Spots Global Cancer Trial Database for Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib

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Trial Identification

Brief Title: Human Absorption, Distribution, Metabolism, and Excretion Study of [14C]Adavosertib

Official Title: A Phase I, Open-Label, Non-Randomised Study of the Absorption, Distribution, Metabolism, and Excretion of Adavosertib After a Single Oral Dose of [14C]Adavosertib to Patients With Advanced Solid Tumours

Study ID: NCT05008913

Conditions

Advanced Solid Tumors

Interventions

[14C]Adavosertib

Study Description

Brief Summary: This is a non-randomised study in patients with advanced solid malignancies

Detailed Description: The aim is to recruit approximately 8 patients with a minimum number of 4 pharmacokinetics (PK) evaluable patients. Each patient will be admitted to the study site pre-dose on Day -1 and will remain at the study site until at least Day 8. Patients will receive a single administration of \[14C\]adavosertib as an oral solution on Day 1. During this study, whole blood, plasma, urine, faeces, and vomit samples (if presented) will be collected at various time points to characterise the absorption, distribution, metabolism, excretion and PK of adavosertib. The duration of the residential period will be evaluated following treatment of the first patient and may be adjusted to ensure recovery of at least 90% of the total radioactivity following the dose of \[14C\]adavosertib and/or until less than 1% of dose is recovered in urine and/or faeces within a 24-hour period.