Conditions: Healthy
Keywords: Healthy volunteer Tepotinib Mesenchymal-epithelial transition factor Translocated promoter region
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
This is a Phase I, open label, randomized, crossover trial to investigate the relative bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference, test. The reference treatment refers to the current Phase II film-coated tablet (5 \* 100 milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III film-coated tablet (1 \* 500 mg film-coated tepotinib tablet).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tepotinib test (Treatment Period 1) intervention 2: Tepotinib reference (Treatment Period 2) intervention 3: Tepotinib reference (Treatment Period 1) intervention 4: Tepotinib test (Treatment Period 2)
Intervention descriptions: intervention 1: Subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 1 (Day 1) intervention 2: Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 2 (Day 22) intervention 3: Subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 1 (Day 1) intervention 4: Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 2 (Day 22)

Protocol document: