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

NCT04387981 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-08-07

No results posted yet for this study

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

DRUG

[14C]-orvepitant

Oral solution of \[14C\]-orvepitant

Sponsors & Collaborators

  • Nerre Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · Quotient Sciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2020-06-28
Completion
2020-06-28
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04387981 on ClinicalTrials.gov