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.
Eligibility
Sex
MALE
Min age
30 Years
Max age
65 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Absolute bioavailability of ontunisertib following oral and IV administration — Through study completion, an average of 8 days Part 1: To determine the absolute oral bioavailability of ontunisertib
Cumulative amount of total radioactivity excreted in urine and feces — Through study completion, an average of 10 days Part 2: To determine the mass balance recovery after a single oral dose of \[14C\]ontunisertib
Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces — Through study completion, an average of 10 days Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of \[14C\]ontunisertib
Trial sites (1)
Facility
City
Region
Status
Quotient Sciences Limited
Nottingham
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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