NCT03546608

Tepotinib Hepatic Impairment Trial

Open-Label, Parallel-Group Phase 1 Study to Investigate the Effect of Various Degrees of Hepatic Impairment on the PK, Safety and Tolerability of the c-Met Kinase Inhibitor Tepotinib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Tepotinib	Participants received a single oral dose of tepotinib in Part 1.

Timeline

• Start date: 2018-06-13
• Primary completion: 2019-02-05
• Completion: 2019-02-05
• First posted: 2018-06-06
• Last updated: 2024-08-12
• Results posted: 2024-08-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study