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ea0089t3 | Trials In Progress | NANETS2022

Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Carcinoid Syndrome

Chauhan, MD Aman , Shaheen, MD Shagufta , Usiskin, MD Keith , Odueyungbo, PhD Ade , Mui, BSc Cosina , Dillon, MD Joseph

Background: Neuroendocrine tumors (NETs) are classified as functional or non-functional based on the presence of characteristic symptoms, related to tumoral secretion of biologically active peptides or amines. Carcinoid Syndrome (CS) is the commonest functional NET syndrome, seen at diagnosis in 19% of patients. It is characterized in over 80% of cases by watery diarrhea (mainly due to serotonin hypersecretion) or cutaneous flushing. Somatostatin is a neuropeptide that inhibit...

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ea0098c8 | Clinical – Chemo/SSA/Biologics | NANETS2023

Effect of hepatic impairment on pharmacokinetics, safety, and tolerability of oral paltusotine, a small-molecule, selective somatostatin receptor subtype 2 agonist

Luo MS Rosa , Casagrande MD, PhD Alessandra , Oun BA Sonic , Wang MSPH Yang , Scott Struthers PhD R. , Usiskin MD Keith , Krasner MD Alan

Background: Paltusotine is an investigational oral, once-daily, small molecule somatostatin receptor type 2 agonist in development for the treatment of acromegaly and carcinoid syndrome associated with neuroendocrine tumors.Methods: This multicenter, open-label, phase 1 study enrolled participants with mild, moderate, and severe hepatic impairment based on Child-Pugh classification and matched healthy participants. A single 20-mg oral dose of paltusotine...

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Endocrine Abstracts

Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Carcinoid Syndrome

Effect of hepatic impairment on pharmacokinetics, safety, and tolerability of oral paltusotine, a small-molecule, selective somatostatin receptor subtype 2 agonist

BiosciAbstracts