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Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects

Healthy Clinical Trial

Official title:
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] Orvepitant in Healthy Male Subjects After Oral Dosing

Clinical Trial Summary

This is a single centre, open-label, non-randomised study to assess the mass balance recovery, absorption, metabolism, and excretion of a single oral dose of [14C]-orvepitant in healthy male subjects. It is planned to enrol 6 subjects. Each subject will receive a single dose of 30 mg [14C] orvepitant containing not more than (NMT) 3.7 megabecquerel (MBq) [14C], administered as an oral solution in the fasted state. Subjects will be admitted in the evening on the day prior to [14C]-orvepitant administration and will be dosed in the morning following an overnight fast. It is planned that subjects will remain resident in the clinical unit until 168 hours post-dose (Day 8) when they will be discharged from the clinical unit. Through the resident period samples (blood, urine, faeces) will be collected and analysed for mass balance, total radioactivity, orvepitant levels. Metabolite profiling and ID will also be performed.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04387981
Study type Interventional
Source Nerre Therapeutics Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 1, 2020
Completion date June 28, 2020
View Details
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