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ACTIVE NOT RECRUITING
NCT06308263
PHASE1

Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303)

Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

This is a single sequence 2-period open label study in participants with advanced solid tumors. The purpose of Period 1 of this study is to assess the mass balance to determine drug-related entities present in circulation and excreta and provide a comprehensive understanding of biotransformation pathways and clearance mechanisms in participants with advanced solid tumors. The purpose of Period 1a is to assess the extent of ABA of tuvusertib and the mass balance, PK, metabolism, and elimination of 14C-tuvusertib after iv dosing in participants with advanced solid tumors. After either Period 1 or Period 1a; participants may enter an optional extension phase (Period 2) where participants will receive tuvusertib until disease progression or other criteria for study intervention discontinuation are met.

Official title: Phase 1 Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, Excretion and Absolute Bioavailability of Tuvusertib (M1774) Containing Microtracer 14C Tuvusertib in Participants With Advanced Solid Tumors (DDRIVER Solid Tumors 303)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-03-25

Completion Date

2026-03-23

Last Updated

2026-01-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tuvusertib [14C]Tuvusertib microtracer

Participants will receive single oral dose of Tuvusertib containing a \[14C\] Tuvusertib microtracer solution on Day 1 of period 1 under fasted conditions.

DRUG

Tuvusertib

Participants will also receive a single oral dose of Tuvusertib on Day 1 of Period 1 or Period 1a, and daily single oral dose of Tuvusertib for 2 weeks in 21 days cycle of Period 2.

DRUG

Tuvusertib + [14C]Tuvusertib microdose bolus injection

In Period 1a, participants will receive on Day 1 of Period 1 a single oral dose of tuvusertib and an intravenous (IV) (14C) tuvusertib microdose as bolus injection.

Locations (1)

Pharmaceutical Research Associates Magyarország Kutatás - Fejlesztési Kft., Klinikai Farmakológiai Vizsgálóhely

Budapest, Hungary