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

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 25, 2024

Primary Completion Date

March 22, 2026

Study Completion Date

March 22, 2026

Conditions
Solid Tumor
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.

Trial Locations (2)

Unknown

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

Észak Pesti Centrum Kórház-Honvédkórház, Onkológiai Osztály, Budapest

All Listed Sponsors
lead

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

INDUSTRY

NCT06308263 - Tuvusertib (M1774) Human Mass Balance and Absolute Bioavailability Study (DDRIVER Solid Tumors 303) | Biotech Hunter | Biotech Hunter