Mass Balance and Absolute Bioavailability of [14C]-VH4011499

Inclusion Criteria:

• Willing and able to sign the informed consent form.

• Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.

• Age: 18 to 55 years, inclusive, at screening.

• Female participants are eligible to participate if they are of non-childbearing potential and are not breastfeeding or planning to breastfeed for at least 12 months following the last dose.

  • Female participants of non-childbearing potential must have unequivocal documentation (either by medical records and/or from the clinical interview) that they are not of childbearing potential (postmenopausal, medically sterile, or surgically sterile). Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration >33.4 milli-international units per milliliter (mIU/mL) at screening to confirm menopause.

• Male participants, if not surgically sterilized, must agree to use a condom when having sexual intercourse with a female partner of childbearing potential from admission to the clinical site on Day -1 until the completion of the follow up visit.

• Male participants must agree not to donate sperm from admission to the clinical site on Day -1 until the completion of the follow-up visit.

• All prescribed medication must have been stopped at least 30 days or >5 half-lives (whichever is longer) prior to admission to the clinical site on Day -1 until completion of the follow-up visit.

• All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site until completion of the follow-up visit. An exception is made for paracetamol (≤ 2 g per day), which is allowed up to admission to the clinical site.

• Good physical and mental health based on medical history, physical examination, clinical laboratory test results, electrocardiogram (ECG), and vital signs, as judged by the Investigator.

Exclusion Criteria:

• History of relevant drug and/or food allergies. - History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the trial drug.
• Using tobacco/nicotine products within 30 days prior to the first trial drug administration. - Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or HIV 1 or 2 antibodies at screening.
• Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment).
• Known history of cirrhosis with or without viral hepatitis co-infection.
• History of clinically relevant hepatitis within the last 6 months.
• Any verified Grade 4 laboratory abnormality. - ALT >1.5x (upper limit of normal [ULN]).
• Total bilirubin >1.5x ULN.
• Estimated glomerular filtration rate (GFR) of <60 mL/min/1.73 m^2.
• QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 msec.
• Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
• Unsuitable veins for infusion or blood sampling. - Participation in a trial with a [14C] dose of ≥0.1 MBq in the period of 1 year prior to screening.
• TRA in plasma must not exceed a [14C] / [12C] ratio of 1.31x10^-12. - Exposure to significant radiation (e.g., serial x-ray or CT scans, barium meal, etc.) in the 3 years prior to screening.
• Irregular defecation pattern (less than once per 2 days).