Absorption, metabolism, and excretion of [14C]-GDC-6036 Not Applicable
Conditions
Interventions
All participants will receive a single oral dose of [14C]-GDC-6036, 100 milligrams (mg) on Day 1 under fasted conditions.
Sponsors
F. Hoffmann-La Roche (Switzerland)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male participants, between 18 and 65 years of age, inclusive 2. Within body mass index (BMI) range 18.0 to 32.0 kilograms per meter square (kg/m²), inclusive 3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs 4. Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], complete blood count [CBC], and urinalysis [UA] with complete microscopic examination) within the reference range for the test laboratory, unless deemed not clinically significant by the investigator 5. Negative test for selected drugs of abuse at Screening 6. Negative hepatitis panel (hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens 7. Participants who have a history of a minimum of 1 bowel movement per day
Exclusion criteria
Exclusion criteria: 1. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs 2. Administration of a COVID-19 vaccine in the past 30 days prior to Screening 3. History of malignancy, except for a history of 5 years or more of appropriately treated non-melanoma skin carcinoma 4. Exposure to significant diagnostic or therapeutic radiation (e.g., serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in (Day -1) 5. Participation in more than three radiolabelled drug studies in the last 12 months (previous study to be at least 4 months prior to Check-in [Day -1] where exposures are known to the investigator or 6 months prior to Check-in [Day -1] for a radiolabelled drug study where exposures are not known to the investigator). The total 12-month exposure from this study and a maximum of two other previous radiolabelled studies within 4 to 12 months prior to this study will be within the CFR-recommended levels considered safe, per US Title 21CFR 361.1
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentages of GDC-6036 and detectable metabolites measured using plasma, bile, urine and faeces at multiple timepoints from Day 1 up to Day 58 2. Percentage of participants with adverse events (AEs) recorded from Day 1 up to Day 58 3. Apparent terminal elimination half-life (t1/2) of M21 metabolite measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay on plasma samples at multiple timepoints from Day 1 up to Day 58 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Concentration of GDC-6036 measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay on plasma samples from Day 1 up to Day 58 2. Concentration of total radioactivity measured using liquid scintillation counting on plasma, whole blood, urine and feces samples from Day 1 up to Day 58 3. Maximum observed concentration (Cmax) of GDC-6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 4. Time to maximum observed concentration (Tmax) of GDC-6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 5. Area under the concentration-time curve from hour 0 to the time of the last measurable concentration (AUC0-t) of GDC -6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 6. Time to the last measurable concentration (Tlast) of GDC-6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 7. Area under the concentration-time curve extrapolated to infinity (AUC0-8) of GDC-6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 8. Apparent terminal elimination rate constant (?z) of GDC-6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 9. Apparent terminal elimination half-life (t1/2) of GDC-6036 measured from plasma samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 10. Maximum observed concentration (Cmax) of total radioactivity measured from plasma and whole blood samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 11. Time to maximum observed concentration (Tmax) of total radioactivity measured from plasma and whole blood samples using model-independent approach at multiple timepoints from Day 1 up to Day 58 12. Area u | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed