Status:
COMPLETED
Mass Balance Study of NV-5138 in Healthy Male Subjects
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
MALE
40-65 years
Phase:
PHASE1
Brief Summary
The objective of this study is to assess the mass balance and routes of excretion of total radioactivity after a single oral dose of 1600 mg \[14C\]-NV-5138.
Eligibility Criteria
Inclusion
- Healthy males aged 40 to 65 years inclusive at the time of signing informed consent.
- Body mass index of 18.0 to 32.0 kg/m2 as measured at screening.
Exclusion
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Subjects who are, or are immediate family members of, a study site or sponsor employee
- Evidence of current SARS-CoV-2 infection
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption of \>21 units per week and (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- A confirmed positive alcohol breath test at screening or admission
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- Subjects with pregnant or lactating partners
- 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. No occupationally exposed worker shall participate in the study
- Subjects who have participated in an ADME study involving carbon-14 within 12 months of screening.
- Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed
- Clinically significant abnormalities on vital signs or ECGs as judged by the investigator at screening or pre-dose
- Confirmed positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody 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, dermatological, chronic respiratory or gastrointestinal disease or neurological disorder, as judged by the investigator
- Any history of major depression disorder (MDD) requiring treatment or counselling or any other clinically significant psychiatric history, as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days or 5 half-lives, whichever is longer, before IMP administration. COVID-19 vaccines are accepted concomitant medications. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as determined by the investigator.
- Subject answers "yes" to "Suicidal Ideation" Items 1 or 2 on the C-SSRS at screening
- Failure to satisfy the investigator of fitness to participate for any other reason.
Key Trial Info
Start Date :
November 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05384977
Start Date
November 11 2021
End Date
December 9 2021
Last Update
May 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS