Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects

Inclusion criteria

• Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
• Must be willing and able to communicate and participate in the whole study
• Must have regular bowel movements
• Must provide written informed consent
• Must agree to adhere to the contraception requirements of the protocol

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
• Subjects who report to have previously received SJP-0008
• Evidence of current SARS-CoV-2 infection
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males >21 units per week
• A confirmed positive alcohol breath test at screening or admission
• Current smokers and those who have smoked within the last 6 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 6 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, as defined in the Ionising Radiation Regulations 2017, shall participate in the study

Other protocol-defined exclusion criteria may apply