Healthy Volunteers
Conditions
Brief summary
This study will investigate how RO7269162 labeled with a carbon tracer (\[14C\]) is absorbed, metabolized, and eliminated by the body after a single dose in healthy male volunteers.
Interventions
DRUG[ 14C]-labeled RO7269162
Participants will receive one oral dose of \[14C\]-labeled RO7269162.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male participants aged 35 to 64 years of age (inclusive), at screening * Body weight ≥ 50 kg and body mass index within the range 18 to 30 kg/m2 (inclusive), at screening * Male participants who, for 3 months after dosing of \[14C\]-RO7269162, agree to: remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol with a partner that is a woman of childbearing potential; remain abstinent or use contraception with a pregnant female partner; refrain from donating sperm
Exclusion criteria
* History or evidence of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease, metabolic disorder, cancer, or cirrhosis * Any disease or condition that could interfere with the conduct of the study or pose an unacceptable risk to the participant * History or evidence of any medical condition that could potentially alter the absorption, metabolism, or elimination of drugs * Surgical history of the gastrointestinal (GI) tract affecting gastric motility or altering the GI tract (with the exception of uncomplicated appendectomy and hernia repair) * History of malignancy * Use of any prescription drugs, herbal supplements, and/or over-the-counter medication (OTC), dietary supplements (vitamins included) within 2 weeks before Day 1. Use of any prohibited food before study start and during the study as defined by the protocol * Likely to need medication during the study period except for those defined by the protocol * Are currently enrolled in, have participated in, or plan to participate in any other clinical study involving an investigational medicinal product or medical device study from within the 30 days directly preceding screening or within 5 times the elimination half-life, if known (whichever is longer), until completion of the follow-up visit * Evidence of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Donation of blood or blood products for transfusion over 100 mL or significant blood loss within 2 months prior to screening through study completion, clinic discharge or early termination, inclusive. Donation of blood or plasma is not allowed throughout the entire study. Receipt of blood products within 2 months prior to Day -1 is not allowed * Clinically significant history of hypersensitivity or allergic reactions * Regular work with ionizing radiation or radioactive material, or exposure to ionizing radiation within 1 year prior to study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of RO7269162 excreted in urine | Up to Day 22 or Day 37 |
| [14C] recovery in urine | Up to Day 22 or Day 37 |
| [14C] recovery in feces | Up to Day 22 or Day 37 |
| Concentration of [14C] in whole blood | Up to Day 22 or Day 37 |
| Plasma concentration of [14C] | Up to Day 22 or Day 37 |
| Plasma concentration of RO7269162 | Up to Day 22 or Day 37 |
Secondary
| Measure | Time frame |
|---|---|
| Amount of RO7269162 metabolites in blood | Up to Day 22 or Day 37 |
| Amount of RO7269162 metabolites excreted in urine | Up to Day 22 or Day 37 |
| Amount of RO7269162 metabolites excreted in feces | Up to Day 22 or Day 37 |
| Incidence and severity of adverse events | Up to Day 22 or Day 37 |
| Amount of RO7269162 metabolites in plasma | Up to Day 22 or Day 37 |
Countries
Netherlands
Outcome results
None listed