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

This is an open, two-part study in healthy male volunteers, aged 30-65 years. This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine (\[14C\]ontunisertib) and determine the routes and rates of elimination of the test medicine.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months) * Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening. * 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 * 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