Healthy participants Not Applicable
Conditions
Interventions
Participants will receive a single dose of [14C/12C]-RO7223280, 1000 milligrams (mg) with a total radioactivity of 1.8 megabecquerel (MBq) [48 microcurie (µCi)] administered as 1-hour intravenous (IV)
Sponsors
Roche (United States)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent and comply with the study protocol according to International Council for Harmonisation (ICH) and local regulations 2. Male participants aged 35 to 64 years old (inclusive) at screening 3. Healthy male participants. Health status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, clinical chemistry, serology, coagulation, and urinalysis. 4. Participants must weigh at least 50 kilograms (kg) and must have a body mass index (BMI) within the range of 18-32 kilograms per square meter (kg/m^2) (inclusive) at screening
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, haematological or allergic disease, metabolic disorder, cancer, or cirrhosis 2. History or evidence of any medical condition potentially altering the absorption, distribution, metabolism, or elimination of drugs. Surgical history of the gastrointestinal tract affecting gastric motility or altering the gastrointestinal tract (with the exception of uncomplicated appendectomy and hernia repair) 3. History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PQ/PR interval >210 milliseconds (ms), QTcF >450 ms) or cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death) 4. History of malignancy 5. Evidence of human immunodeficiency virus (HIV) infection and/or positive for human HIV antibodies 6. Presence of hepatitis B surface antigen or positive hepatitis C antibody test result at screening or within 3 months prior to study drug administration 7. History of hypersensitivity to any of the excipients in the formulation of RO7223280 8. Infrequent bowel movements (less than once per 24 hours on average) 9. Regular work with ionizing radiation or radioactive material 10. Participants who plan to attempt to father children within 3 months after the study drug administration 11. Participants who have been exposed to ionizing radiations within one year prior to study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Total drug-related [14C]-radioactivity of [14C]-labelled RO7223280 measured as cumulative percentage of [14C]-radioactive dose recovered (%Fe) in urine and faecal samples collected at pre-dose and multiple timepoints post-dose up to Day 22 2. Cumulative amount of total drug-related [14C]-radioactivity of [14C]-labelled RO7223280 during the sampling period, calculated as the sum of amount of total drug-related [14C]-radioactivity excreted (Ae) for each collection interval measured from urine and faecal samples collected at pre-dose and multiple timepoints post-dose up to Day 22 3. Maximum observed blood or plasma concentration (Cmax) of [14C]-Radioactivity and plasma concentration of [12C]-RO7223280 (and its metabolite(s), as appropriate) measured from blood or plasma samples collected at pre-dose and multiple timepoints post-dose up to Day 22 4. Time to maximum observed blood or plasma concentration (Tmax) of [14C]-radioactivity and plasma concentration of [12C]-RO7223280 (and its metabolite(s), as appropriate) measured from blood or plasma samples collected at pre-dose and multiple timepoints post-dose up to Day 22 5. Area under the plasma or blood concentration versus time curve from time zero to the last measurable concentration (AUClast) of [14C]-radioactivity and of [12C]-RO7223280 (and its metabolite(s), as appropriate) measured from blood or plasma samples collected at pre-dose and multiple timepoints post-dose up to Day 22 6. Area under the plasma or blood concentration versus time curve from time zero extrapolated to infinity (AUCinf) of [14C]-radioactivity and of [12C]-RO7223280 (and its metabolite(s), as appropriate) measured from blood or plasma samples collected at pre-dose and multiple timepoints post-dose up to Day 22 7. Apparent terminal half-life (T1/2) of [14C]-radioactivity and of [12C]-RO7223280 (and its metabolite(s), as appropriate) measured from | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Concentration of human metabolites of RO7223280 (as appropriate) measured in plasma, blood, urine, and faecal samples collected at pre-dose and multiple timepoints post-dose up to Day 22 2. Percentage of participants with adverse events (AEs) and severity of AEs, with severity being determined according to National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE V5.0) from screening up to 7 days after the final collection of samples (up to approximately 8 weeks) 3. Number of participants with change from baseline in vital signs measured using temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure from screening up to 7 days after the final collection of samples (up to approximately 8 weeks) 4. Number of participants with change from baseline in physical examination parameters measured by assessments of the cardiovascular, respiratory, gastrointestinal, dermatological, neurological, and musculoskeletal systems, in addition to head, eyes, ears, nose, throat, neck and lymph nodes from screening up to 7 days after the final collection of samples (up to approximately 8 weeks) 5. Number of participants with change from baseline in electrocardiogram (ECG) readings measured using triplicate 12-lead ECG from screening up to 7 days after the final collection of samples (up to approximately 8 weeks) 6. Number of participants with change from baseline in laboratory test results measured using blood and urine samples from screening up to 7 days after the final collection of samples (up to approximately 8 weeks) | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials
Outcome results
None listed