NCT04098692

Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects

A Phase 1, Two-part, Open-label, Single-oral-dose Study to Investigate the Absolute Bioavailability and Absorption, Pharmacokinetics, Distribution, Metabolism, and Excretion of [14C]-Derazantinib in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profiling and identification of derazantinib.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Derazantinib capsule	300 mg derazantinib oral administration (3x100 mg capsules)
DRUG	[14C]-Derazantinib solution for infusion	100 μg \[14C\]-derazantinib intravenous administration
DRUG	[14C]-Derazantinib capsule	300 mg \[14C\]-derazantinib oral administration (3x100 mg capsules)

Timeline

• Start date: 2019-08-08
• Primary completion: 2019-11-18
• Completion: 2019-11-18
• First posted: 2019-09-23
• Last updated: 2021-01-19

Locations

1 site across 1 country: United Kingdom