Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
ConditionFibrostenotic Crohn's Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age30-65
SponsorAgomab Spain S.L.U.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ontunisertib
- [14C]ontunisertib
- [14C]ontunisertib
Treatment groups
8 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov