Mass Balance Study of NV-5138 in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: [14C]-NV-5138
- Registration Number
- NCT05384977
- Lead Sponsor
- Supernus Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]-NV-5138 [14C]-NV-5138 \[14C\]-NV-5138 oral solution
- Primary Outcome Measures
Name Time Method Cumulative total radioactivity in urine and faeces urine and fecal samples up to 168 hours post dose The percentage of the radioactive dose recovered in urine, faeces and in total
- Secondary Outcome Measures
Name Time Method AUClast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood up to 168 hours post-dose Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration
Cmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood up to 168 hours post-dose Maximum observed concentration
t1/2 for NV-5138 and total radioactivity in plasma and whole blood up to 168 hours post-dose Terminal elimination half-life
CL/F for NV-5138 in plasma up to 168 hours post-dose Total oral clearance
MPR Cmax in plasma up to 168 hours post-dose metabolite to parent ration based on Cmax
MPR AUCinf in plasma up to 168 hours post-dose metabolite to parent ration based on AUCinf
CLR for NV-5138 up to 168 hours post-dose Renal clearance
%Dose for total radioactivity in urine and feces up to 168 hours post-dose amount of total radioactivity eliminated in faeces expressed as a percentage of the radioactive dose administered over each sampling period
Characterization of metabolites in plasma, urine and fecal homogenates up to 168 hours post-dose Identification and quantification NV-5138 related metabolites
Ae for total radioactivity in urine and feces up to 168 hours post-dose amount of total radioactivity excreted over each sampling period
Tlast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood up to 168 hours post-dose Time of the last measurable concentration
Vz/F for NV-5138 in plasma up to 168 hours post-dose Apparent volume of distribution
Whole blood to plasma partitioning for total radioactivity up to 168 hours post-dose The AUCinf ratio of whole blood to plasma
AUCinf for NV-5138, metabolite M8 and total radioactivity in plasma whole blood up to 168 hours post-dose Area under the concentration-time curve from time zero (pre-dose) to infinity
Tmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood up to 168 hours post-dose Time of maximum observed concentration
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Ruddington, Nottingham, United Kingdom