Evaluation of the Pharmacokinetics of Trazpiroben (TAK-906), a Peripherally Selective D₂/D₃ Dopamine Receptor Antagonist, in the Presence and Absence of Itraconazole, a Potent CYP 3A4 Inhibitor.

ABSTRACT:

Purpose

Treatment options for gastroparesis, such as metoclopramide and domperidone, are limited because of safety concerns, which may be exacerbated in the presence of inhibitors of drug metabolism. This study evaluated the effect of itraconazole on the pharmacokinetics, safety, and tolerability of trazpiroben (previously TAK-906), a novel, peripherally selective D₂/D₃ dopamine receptor antagonist.

Methods

This was a phase 1, two-period, crossover trial in healthy participants (NCT03161405). On day 1, period 1 (days 1-3), participants received a single oral dose of trazpiroben 25 mg. During period 2 (days 4-9), participants received oral itraconazole 200 mg once daily (days 1-5) and one oral dose of trazpiroben 25 mg post itraconazole on day 4. Trazpir

SUBMITTER: Chen C 

PROVIDER: S-EPMC8285519 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature