A Study to Evaluate Metabolism, Excretion, and Mass Balance of [14C]Vapendavir

Inclusion criteria

• Must provide written informed consent
• Must be willing and able to communicate and participate in the whole study
• Participants must demonstrate their ability to swallow 8 capsules
• Aged 30 to 65 years inclusive at the time of signing informed consent
• Must agree to adhere to the study contraception requirements
• Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12- lead ECG, and laboratory safety tests without any clinically significant abnormalities
• Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
• Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)

Exclusion criteria

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
• Acute diarrhea or constipation in the 7 days before the predicted Day 1
• Participants who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening
• Clinically significant abnormal laboratory values at screening as judged by the investigator
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
• Evidence of renal impairment at screening
• Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer
• 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, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
• Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 3 g of paracetamol per day) in the 14 days before dosing
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption >21 units per week (1 unit = 1⁄2 pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 = 125 mL glass of wine, depending on type)
• A confirmed positive alcohol breath test
• Current smokers and those who have smoked within the last 12 months
• Current users of e-cigarettes or nicotine replacement products and those who have used these products within the last 12 months
• A confirmed breath carbon monoxide reading of greater than 10 ppm
• Confirmed positive drugs of abuse test result
• Male participants with pregnant or lactating partners
• Participants who are, or are immediate family members of, a study site or sponsor or employee
• Failure to satisfy the investigator of fitness to participate for any other reason