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.

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523158-15-00

Acronym

RGL-RET-001

Enrollment

Registered

2025-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced or metastatic solid tumors

Brief summary

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)

Detailed description

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)

Interventions

DRUGGAVRETO ®(pralsetinib) capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026