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Healthy VolunteersPhase 1NCT05384977

Mass Balance Study of NV-5138 in Healthy Male Subjects

A Phase 1 study testing [14C]-NV-5138 in people with Healthy Volunteers, run by Supernus Pharmaceuticals, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[14C]-NV-5138
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
11 Nov 2021to 9 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: An Open-label, Single Dose, Mass Balance Study to Assess the Disposition of [14C]-NV-5138 in Healthy Male Subjects

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.

Being tested
[14C]-NV-5138

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-NV-5138Drug

    Single dose, given as oral solution, 1600 mg

Study groups in NCT05384977
Study groupRoleWhat they receive
[14C]-NV-5138Experimental[14C]-NV-5138 oral solution
Receives: Drug: [14C]-NV-5138

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative total radioactivity in urine and faeces

    The percentage of the radioactive dose recovered in urine, faeces and in total

    Measured: urine and fecal samples up to 168 hours post dose

Secondary outcomes (15)

  1. AUCinf for NV-5138, metabolite M8 and total radioactivity in plasma whole blood

    Area under the concentration-time curve from time zero (pre-dose) to infinity

    Measured: up to 168 hours post-dose

  2. AUClast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood

    Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration

    Measured: up to 168 hours post-dose

  3. Cmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood

    Maximum observed concentration

    Measured: up to 168 hours post-dose

  4. Tmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood

    Time of maximum observed concentration

    Measured: up to 168 hours post-dose

  5. Tlast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood

    Time of the last measurable concentration

    Measured: up to 168 hours post-dose

  6. t1/2 for NV-5138 and total radioactivity in plasma and whole blood

    Terminal elimination half-life

    Measured: up to 168 hours post-dose

  7. CL/F for NV-5138 in plasma

    Total oral clearance

    Measured: up to 168 hours post-dose

  8. Vz/F for NV-5138 in plasma

    Apparent volume of distribution

    Measured: up to 168 hours post-dose

  9. MPR Cmax in plasma

    metabolite to parent ration based on Cmax

    Measured: up to 168 hours post-dose

  10. MPR AUCinf in plasma

    metabolite to parent ration based on AUCinf

    Measured: up to 168 hours post-dose

  11. Whole blood to plasma partitioning for total radioactivity

    The AUCinf ratio of whole blood to plasma

    Measured: up to 168 hours post-dose

  12. CLR for NV-5138

    Renal clearance

    Measured: up to 168 hours post-dose

  13. Ae for total radioactivity in urine and feces

    amount of total radioactivity excreted over each sampling period

    Measured: up to 168 hours post-dose

  14. %Dose for total radioactivity in urine and feces

    amount of total radioactivity eliminated in faeces expressed as a percentage of the radioactive dose administered over each sampling period

    Measured: up to 168 hours post-dose

  15. Characterization of metabolites in plasma, urine and fecal homogenates

    Identification and quantification NV-5138 related metabolites

    Measured: up to 168 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start11 Nov 2021
  3. Primary completion9 Dec 2021
  4. Study completion9 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384977
Sponsor's protocol ID
NAV-17A-006
Status last verified
Oct 2021
First submitted
12 May 2022
Last updated
23 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-NV-5138 in people with Healthy Volunteers, run by Supernus Pharmaceuticals, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative total radioactivity in urine and faeces (time frame: urine and fecal samples up to 168 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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