A study evaluating the absorption, metabolism, and excretion of [14C]-GDC-6036 following a single oral dose in healthy male participants
- Conditions
- Absorption, metabolism, and excretion of [14C]-GDC-6036Not Applicable
- Registration Number
- ISRCTN10152571
- Lead Sponsor
- F. Hoffmann-La Roche (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 8
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method