Open, Single-dose/-Period Study to Assess Mass Balance Recovery, Metabolite Profile/Identification of 14C-Varlitinib

Summary

This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects. It is planned to enrol a single cohort of 6 healthy male subjects to ensure data in 4 evaluable subjects. Each subject will receive a single administration of 120 mg \[14C\] varlitinib oral suspension containing not more than (NMT) 2.9 MBq (79 µCi), in the fed state.

Timeline

Start

2017-11-23

Primary completion

2017-12-06

Completion

2017-12-14

Drugs

Indications

No indication recorded.