Mass Balance Study of NV-5138 in Healthy Male Subjects.

Navitor Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C]-NV-5138

Study type

Interventional

Funder types

Industry

Identifiers

NCT05152680

NAV-17A-006

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.