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Mass balance, metabolism, and pharmacokinetics of [¹⁴C]amdizalisib, a clinical-stage novel oral selective PI3Kδ inhibitor for the treatment of non-hodgkin's lymphoma, in healthy Chinese volunteers.

ABSTRACT: Amdizalisib (HMPL-689) is an ATP-competitive PI3Kδ inhibitor currently under investigation for treating Hodgkin's lymphoma. This study aimed to evaluate the metabolism, excretion, pharmacokinetics, and safety profile of amdizalisib in healthy human subjects to support its clinical application. This Phase I clinical trial included six healthy Chinese male volunteers who received a single oral dose of 30 mg/100 µCi [14C]amdizalisib suspension. Blood, urine, and fecal samples were collected to analyze pharmacokinetics, metabolic pathways, and excretion patterns. Amdizalisib was rapidly absorbed, with a median Tmax of 2.5 h. The Cmax of 244 ± 48.9 ng/mL, and AUC0-t was 1870 ± 474 h ng/mL after a single oral dose. The blood-to-plasma total radioactivity ratio ranged from 0.561 to 0.645, indicat

SUBMITTER: Zhao CY

PROVIDER: S-EPMC11605291 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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Dataset Information

Mass balance, metabolism, and pharmacokinetics of [¹⁴C]amdizalisib, a clinical-stage novel oral selective PI3Kδ inhibitor for the treatment of non-hodgkin's lymphoma, in healthy Chinese volunteers.

OmicsDI is part of the ELIXIR infrastructure

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Dataset Information

Mass balance, metabolism, and pharmacokinetics of [14C]amdizalisib, a clinical-stage novel oral selective PI3Kδ inhibitor for the treatment of non-hodgkin's lymphoma, in healthy Chinese volunteers.

OmicsDI is part of the ELIXIR infrastructure

Tweets

Mass balance, metabolism, and pharmacokinetics of [¹⁴C]amdizalisib, a clinical-stage novel oral selective PI3Kδ inhibitor for the treatment of non-hodgkin's lymphoma, in healthy Chinese volunteers.