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

NCT04387981 | Completed Phase 1 FDA Drug

• 1 other identifier: ORV-1-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of radioactive dose recovered in urine and faeces and total percentage

  168 hours

• Concentration of total radioactivity in blood and plasma

  168 hours

Study Arms (1)

[14C]-orvepitant

EXPERIMENTAL

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

Drug: [14C]-orvepitant

Interventions

[14C]-orvepitant DRUG

Oral solution of \[14C\]-orvepitant

Also known as: orvepitant

[14C]-orvepitant

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nerre Therapeutics Ltd.: lead

Study Sites (1)

Quotient Sciences

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

orvepitant

Study Officials

• Principal Investigator

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single dose

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 14, 2020
• Study Start: June 1, 2020
• Primary Completion: June 28, 2020
• Study Completion: June 28, 2020
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)