Phase 1 Crohn's Disease and Colitis Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- Men between the ages of 30 and 65 years old at the time of signing the consent form.
- People who agree to use an adequate form of contraception for up to 93 days after the last dose of the trial treatment.
- Men considered to be in good general health by the study doctor, based on a full medical history, physical check-up, blood pressure and heart rate measurements, heart tracing (ECG), and blood and urine tests showing no significant problems.
- People with a body weight in a healthy range, specifically a body mass index (a measure of weight relative to height) between 18.0 and 29.9 kg/m².
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have had a serious allergic reaction or serious sensitivity to any medicine or its ingredients.
- People with a history of significant kidney, liver, breathing, digestive, nerve, or mental health conditions — including conditions such as peptic ulcers, significant gastrointestinal bleeding, ulcerative colitis, Crohn's Disease, or Irritable Bowel Syndrome.
- People who have had surgery on their digestive system, except for appendix removal or hernia repair — unless that surgery was performed within the past 12 months.
- People whose blood, urine, or other standard health test results show significant abnormalities, as determined by the study doctor at the screening stage.
- People whose total radiation exposure in the past 12 months exceeds 5 mSv, or whose exposure in the past 5 years exceeds 10 mSv — this includes X-rays and other medical scans, but not natural background radiation; people who work in jobs with regular radiation exposure are also not eligible.
- People who have taken an investigational medicine as part of an ADME study, or any study involving a radioactive substance called Carbon-14, within the last 12 months (confirm with trial site).
- Men whose partner is currently pregnant or breastfeeding.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Silke Hüttner, MD, Agomab Therapeutics
Phone: 0032 3318 91 70
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Absolute bioavailability of ontunisertib following oral and IV administration; Cumulative amount of total radioactivity excreted in urine and feces; 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
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.