ArticleClinical pharmacology in drug development2026
Phase 1 Study of Paltusotine, a Novel Oral Once‑Daily, Nonpeptide Selective Somatostatin Receptor 2 Agonist, in Healthy Japanese Adults.
Article in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Paltusotine is a novel, nonpeptide, once-daily oral, selective somatostatin 2 receptor (SST2) agonist. We evaluated the pharmacokinetics, pharmacodynamics, and safety of oral paltusotine in healthy Japanese adults in single‑dose (20, 40, 60, 80 mg) and repeated‑dose (40 mg once daily for 7 days in a two-sequence, two‑period crossover design) studies. In addition, the effects of food intake and pharmacodynamics were examined in the repeated-dose study. Eight participants were enrolled in each dose of the single-dose study, and 12 participants were enrolled in the repeated-dose study. In both studies, there were no deaths, serious adverse events, or severe adverse events. In the single-dose study, plasma paltusotine exposures increased in a dose-dependent manner for the dose range of 20 to 80 mg (based on C
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