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Clinical Trial ยท PHASE1 ยท Recruiting

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

07 September 2026 NCT07672574 ClinicalTrials.gov โ†—
✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE1
Participants
MALE
Age Range
30 Years โ€“ 65 Years

About This Trial

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.

Who Can Join?

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…

⚠ Always speak to your doctor before applying to any clinical trial.

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