Clinical trial NCT05152680: Mass Balance Study of NV-5138 in Healthy Male Subjects.
Official title: An Open-label, Single Dose, Mass Balance Study to Assess the Disposition of [14C]-NV-5138 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Navitor Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Supernus Pharmaceuticals, Inc.
First posted: 2021-12-10
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Cumulative total radioactivity in urine and faeces
timeFrame: urine and fecal samples up to 168 hours post dose
Secondary outcomes:
measure: AUCinf for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
timeFrame: up to 168 hours post-dose
measure: AUClast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
timeFrame: up to 168 hours post-dose
measure: Cmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
timeFrame: up to 168 hours post-dose
measure: Tmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
timeFrame: up to 168 hours post-dose
measure: Tlast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
timeFrame: up to 168 hours post-dose
measure: t1/2 for NV-5138 and total radioactivity in plasma and whole blood
timeFrame: up to 168 hours post-dose
measure: CL/F for NV-5138 in plasma
timeFrame: up to 168 hours post-dose
measure: Vz/F for NV-5138 in plasma
timeFrame: up to 168 hours post-dose
measure: MPR Cmax in plasma
timeFrame: up to 168 hours post-dose
measure: MPR AUCinf in plasma
timeFrame: up to 168 hours post-dose
measure: Whole blood to plasma partitioning for total radioactivity
timeFrame: up to 168 hours post-dose
measure: CLR for NV-5138
timeFrame: up to 168 hours post-dose
measure: Ae for total radioactivity in urine and feces
timeFrame: up to 168 hours post-dose
measure: %Dose for total radioactivity in urine and feces
timeFrame: up to 168 hours post-dose or until mass balance criteria have been met
measure: Incidence of treatment-emergent adverse events
timeFrame: through study completion at one week
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
References: