A Study to Learn How ASP3082 is Processed in Healthy Men
ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-65
SponsorAstellas Pharma Global Development, Inc.
About this trial
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers.
To do this, \[14C\] which is a certain chemical (called a tracer, or radionuclide) has been added to setidegrasib. \[14C\] gives off radiation, but the dose is very low (about the same as the dose from an x-ray) and will leave the body within a few days. \[14C\] will be picked up by a scanner and will be used to follow setidegrasib through the body. \[14C\]setidegrasib will be given as 1 single injection slowly through a vein (infusion).
The men will stay overnight in the clinic for at least 2 weeks. They will give regular blood, urine and stool samples during their stay and will be closely monitored. The men will return to the clinic about 1 week later for a final safety check.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant is healthy and has no clinically significant medical conditions based on the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
Participant has regular bowel habits (i.e., at least 1 bowel movement per day).
Must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the investigational period and for 3 months after study intervention administration.
Must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after study intervention administration.
Disqualifiers
Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence).
Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 8 to 9 days) after the dose of study drug administration or end-of-study visit (ESV), whichever is longer.
Participant has previously undergone a cholecystectomy.
Trial design
Design model
Single group
Treatments tested in this trial
14C-labeled ASP3082
DrugIntravenous infusion
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: 14C-labeled ASP3082Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pharmacokinetics (PK) of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK whole blood samples collected.
Time frame
Up to 21 days2
PK of 14C-labeled ASP3082 (radioactivity in whole blood): area under the concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK whole blood samples collected.
Time frame
Up to 21 days3
PK of 14C-labeled ASP3082 (radioactivity in whole blood): maximum concentration (Cmax)
Cmax will be recorded from the PK whole blood samples collected.
Time frame
Up to 21 days4
PK of 14C-labeled ASP3082 (radioactivity in plasma): AUCinf
AUCinf will be recorded from the PK plasma samples collected.
Time frame
Up to 21 daysSecondary outcomes
1
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Time frame
Up to 30 days2
Number of Participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame
Up to 30 days3
Number of Participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame
Up to 30 days4
Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Time frame
Up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov