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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-orvepitant | Experimental | [14C]-orvepitant administered as 30mg single dose in oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-orvepitant | Drug | Oral solution of [14C]-orvepitant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of radioactive dose recovered in urine and faeces and total percentage | 168 hours | |
| Concentration of total radioactivity in blood and plasma | 168 hours |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| C584555 | orvepitant |
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Open label, single dose
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