Clinical trial NCT04387981: Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Nerre Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single dose
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Key Inclusion Criteria:

* Healthy males
* Aged 30 to 65 years inclusive at the time of signing informed consent.
* Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening.
* Must provide written informed consent.
* Must agree to adhere to the contraception requirements

Key Exclusion Criteria:

* History of any drug or alcohol abuse in the past 2 years.
* Regular alcohol consumption \>21 units per week.
* Current smokers and those who have smoked within the last 12 months.
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* Clinically significant abnormal clinical chemistry, haematology, or urinalysis as judged by the Investigator.
* Subjects with a presence of any of the following at screening: bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \>1.5 × the upper limit of normal.
* Confirmed positive drugs of abuse test result.
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
* Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<80 mL/min using the Cockcroft-Gault equation.
* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, or GI disease, neurological or psychiatric disorder, as judged by the Investigator.

Primary outcomes:
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: 168 hours
measure: Concentration of total radioactivity in blood and plasma
timeFrame: 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
affiliation: Quotient Sciences
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: