NCT04387981

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Nerre Therapeutics Ltd. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-orvepitant	Oral solution of \[14C\]-orvepitant

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-06-28
• Completion: 2020-06-28
• First posted: 2020-05-14
• Last updated: 2020-08-07

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study