A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males

Inclusion criteria

• Healthy males
• Aged 30 to 65 years of age
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
• Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination)
• Must have been willing and able to communicate and participate in the whole study
• Must have had regular bowel movements (i.e. average stool production of ≥1 and

≤3 stools per day)

• Must have provided written informed consent
• Must have adhered to the contraception requirements defined in Section 9.4 of the protocol (Appendix 16.1.1)

Exclusion criteria

• Subjects who had received any IMP in a clinical research study within the previous 3 months or a similar 14C radioactive clinical trial within the previous 12 months
• Subjects who were study site employees, or immediate family members of a study site or sponsor employee
• Subjects who had previously been enrolled in this study.
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males >21 units per week (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)
• Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening and admission
• Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeded 5 millisieverts (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, was to participate in the study
• Subjects who did not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator at screening
• Clinically significant abnormality on electrocardiogram (ECG) as judged by the investigator
• Clinically significant abnormal biochemistry, hematology or urinalysis at screening as judged by the investigator (laboratory parameters are listed in Appendix 1 of the protocol, Appendix 16.1.1)
• Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1 of the protocol, Appendix 16.1.1)
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder, 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. Hayfever was allowed unless it was active
• Donation or loss of greater than 400 mL of blood within the previous 3 months
• Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (see Section 11.4 of the protocol, Appendix 16.1.1). Exceptions may have applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
• Failure to satisfy the investigator of fitness to participate for any other reason