![Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers](data:image/svg+xml,%3Csvg xmlns=%22http://www.w3.org/2000/svg%22 width=%22600%22 height=%22400%22 viewBox=%220 0 600 400%22%3E%3C/svg%3E)
Cure8 trial brief
Drug developers use mass-balance (ADME) studies to learn how a new drug is absorbed and cleared, which helps guide dosing, safety testing, and further trials.
For people following Crohn's disease research, this trial indicates ontunisertib is undergoing early clinical pharmacology work in a development program that lists fibrostenotic Crohn's disease as a condition of interest.
Researchers and clinicians involved in IBD drug development; patients and advocates tracking new investigational therapies for fibrostenotic Crohn's disease.
This is a Phase 1, open two-part mass-balance (ADME) study of ontunisertib in healthy male volunteers that will use 14C-radiolabelled doses (oral and a micro IV dose) to measure absorption, distribution, metabolism, and excretion. Participants will remain in-clinic for sampling and may collect urine and feces at home until mass-balance criteria are met.
The study is recruiting, plans to enroll about eight participants, and lists Fibrostenotic Crohn's Disease as the condition of interest though the trial population is healthy male volunteers.
Primary objectives include determining absolute oral bioavailability and mass-balance recovery, and characterizing metabolites that account for substantial circulating or excreted radioactivity.
This record describes methods, eligibility, and outcome measures (bioavailability, cumulative radioactivity excreted, metabolite profiling) rather than treatment effects or clinical benefits. It is useful mainly as an early ADME study in the development program for ontunisertib.
This is a Phase 1 ADME (mass-balance) study in healthy volunteers using carbon-14 radiolabel to map drug metabolism and excretion. It reports study design and planned measurements but does not present results.
The trial is small (planned N=8) and restricted to healthy male volunteers, so findings will inform pharmacology and safety assessments rather than provide clinical efficacy data in patients.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
People with Crohn's disease who develop symptomatic intestinal strictures currently often need endoscopic dilation or surgery. This trial tests an investigational oral drug (ontunisertib) aiming to improve...
This trial targets fibrotic narrowings (strictures) in Crohn’s disease — a common complication without approved drug treatments — so positive results could change care options and reduce the need for surgery.
People with Crohn's disease often develop intestinal fibrosis and strictures that current drugs don't reverse; a growing drug pipeline aiming at anti‑fibrotic therapies could change future treatment options.
