NCT03484585

Rogaratinib (BAY1163877) Human Mass Balance Study

Single Center, Open-label, Non-randomized, Non-placebo-controlled Study to Investigate the Metabolism, Excretion Pattern, Mass Balance, Safety, Tolerability and Pharmacokinetics After Single Administration of 200 mg [14C]Rogaratinib (Oral Solution) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 200 mg dose of \[14C\]rogaratinib given as a solution. For further clinical development, human mass balance data are required to elucidate the absorption, distribution, metabolism, and excretion (ADME) of rogaratinib.

Conditions

• Clinical Trial, Phase I
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Rogaratinib (BAY1163877)	Single dose, intake orally, 200 mg

Timeline

• Start date: 2018-04-06
• Primary completion: 2018-05-25
• Completion: 2018-08-09
• First posted: 2018-04-02
• Last updated: 2018-08-14

Locations

1 site across 1 country: Netherlands