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

NCT ID: NCT04387981

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-06-28

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C]-orvepitant

\[14C\]-orvepitant administered as 30mg single dose in oral solution

Group Type: EXPERIMENTAL

[14C]-orvepitant

Intervention Type: DRUG

Oral solution of \[14C\]-orvepitant

Interventions

[14C]-orvepitant

Oral solution of \[14C\]-orvepitant

Intervention Type: DRUG

Other Intervention Names

orvepitant

Eligibility Criteria

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

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nerre Therapeutics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

Quotient Sciences

Locations

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

ORV-1-02

Identifier Type: -

Identifier Source: org_study_id