Status:
COMPLETED
Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male Subjects
Lead Sponsor:
Nerre Therapeutics Ltd.
Conditions:
Healthy
Eligibility:
MALE
30-65 years
Phase:
PHASE1
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 subject...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04387981
Start Date
June 1 2020
End Date
June 28 2020
Last Update
August 7 2020
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom