Mass Balance Study of NV-5138 in Healthy Male Subjects

NCT05384977 | Completed Phase 1

• 1 other identifier: NAV-17A-006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Cumulative total radioactivity in urine and faeces

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

  urine and fecal samples up to 168 hours post dose

Secondary Outcomes (15)

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

  up to 168 hours post-dose

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

  up to 168 hours post-dose

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

  up to 168 hours post-dose

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

  up to 168 hours post-dose

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

  up to 168 hours post-dose

Study Arms (1)

[14C]-NV-5138

EXPERIMENTAL

\[14C\]-NV-5138 oral solution

Drug: [14C]-NV-5138

Interventions

[14C]-NV-5138 DRUG

Single dose, given as oral solution, 1600 mg

[14C]-NV-5138

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 23, 2022
• Study Start: November 11, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: May 23, 2022

Record last verified: 2021-10

Locations

GB (1)