Effect of ripretinib on the pharmacokinetics (PK) of midazolam (MDZ), a sensitive CYP3A probe substrate, in adult patients (pts) with advanced gastrointestinal stromal tumor (GIST).

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This study aims to assess how ripretinib affects the pharmacokinetics of midazolam in patients with advanced GIST.
Open-label design with 18 patients administered a single oral 2-mg dose of midazolam, followed by 150 mg ripretinib from cycle 1 day 3.
Pharmacokinetics of midazolam and its metabolite were analyzed through noncompartmental analysis, collecting samples over 48 hours after dosing.
Adverse events were monitored throughout the treatment.
16 patients (89%) were evaluable for pharmacokinetics with no significant changes in C max or AUC of midazolam and 1'-OH midazolam when coadministered with ripretinib.
Geometric mean ratios for C max and AUC were within bioequivalence limits, indicating no significant interaction.
All patients experienced at least one treatment-emergent adverse event, with consistent safety profile unrelated to the study treatment.

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Evaluates the impact of ripretinib on midazolam pharmacokinetics in advanced GIST, indicating its limited interaction with CYP3A.

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Viswanathan et al. (2026) studied this question.

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