A multi-center, open-label, drug-drug interaction study to evaluate the effect of pralsetinib (Gavreto) on the pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 substrates, and hormones estradiol/norethisterone acetate in patients with advanced or metastatic solid tumors.

Condition studied

Patients with advanced or metastatic solid tumors

Investigational medicinal product(s)

Eligibility

Primary endpoint

The following PK parameters will be estimated for the probe substrates and their relevant metabolites: • Area under the plasma concentration-time curve from zero to 24 hours (AUC0-inf) • Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) • Maximum (peak) plasma concentration (Cmax)

Endpoint detail

The following PK parameters will be estimated for the probe substrates and their relevant metabolites: • Time to maximum plasma concentration (tmax) • Terminal half-life (t1/2) • Percent of area under the plasma concentration-time curve obtained at extrapolation (%AUCex) • Mean residence time (MRT) • Terminal elimination rate constant (λz) • Apparent total body clearance (CL/F) • Apparent volume of distribution (Vz/F)