Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers

Prior treatment

• History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
• Radiation exposure, including that from the present trial, 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 trial

Other illness

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• History of clinically significant renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorder

Other

• Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening.
• Participants who have been administered IMP in an ADME trial or any trial involving administration of 14C radioactivity in the last 12 months
• Male participants with pregnant or lactating partners

• Males aged 30 to 65 years inclusive at the time of signing informed consent
• Must agree to the use of an adequate method of contraception for up to 93 days post-final dose
• 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 of 18.0 to 29.9 kg/m2