Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
ConditionFibrostenotic Crohn's Disease
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Ontunisertib
DrugOral capsule
[14C]ontunisertib
DrugIV infusion
[14C]ontunisertib
DrugOral capsule
Treatment groups
8 Participants
are divided into 3 treatment groupsGroup A: OntunisertibExperimental treatment 1 intervention
Group B: [14C]ontunisertib solution for infusionExperimental treatment 1 intervention
Group C: [14C]ontunisertibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Absolute bioavailability of ontunisertib following oral and IV administration
Part 1: To determine the absolute oral bioavailability of ontunisertib
Time frame
Through study completion, an average of 8 days2
Cumulative amount of total radioactivity excreted in urine and feces
Part 2: To determine the mass balance recovery after a single oral dose of \[14C\]ontunisertib
Time frame
Through study completion, an average of 10 days3
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
Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of \[14C\]ontunisertib
Time frame
Through study completion, an average of 10 daysSecondary outcomes
1
PK parameter (AUClast)
Part 1: To characterize the IV PK (AUClast) of \[14C\]ontunisertib and total radioactivity in plasma
Time frame
Through study completion, an average of 8 days2
Cumulative amount of total radioactivity excreted in urine and feces following IV administration
Part 1: To determine the mass balance recovery after a single IV dose of \[14C\]ontunisertib
Time frame
Through study completion, an average of 8 days3
PK parameter (AUClast)
Part 1 and Part 2: To characterize the plasma PK (AUClast) of ontunisertib and metabolites and total radioactivity (Part 2 only) following a single oral dose
Time frame
Through study completion, an average of 18 days4
Whole blood-to-plasma concentration ratios for total radioactivity
Part 2: To evaluate the extent of distribution of total radioactivity into blood cells
Time frame
Through study completion, an average of 10 daysSponsors and contacts
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Source ClinicalTrials.gov