Schizophrenia
Conditions
Interventions
Subjects will be given Ralmitaront as 3 capsules with 240 milliliters (mL) of
(tap) water after an overnight fast of at least 10 hours. Fasting continues for
another 4 hours after dosing. Water is a
Sponsors
F. Hoffman-La Roche Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonisation (ICH) and local regulations. 2. Healthy participants aged 18 to 55 years of age, inclusive, at the time of signing the ICF. 3. Male participants who are overtly healthy (defined by absence of evidence of any active or chronic disease) as determined by medical evaluation including: • A detailed medical and surgical history • A complete physical examination • Vital signs • 12-lead ECG • Hematology • Blood chemistry • Serology and urinalysis 4. Fluent in the language of the Investigator and study staff (Dutch or English), and able to communicate with the study staff. 5. Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive at screening. 6. Male participants During the treatment period and for at least 90 days after the final dose of RO6889450 agreement to: • Remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of
Exclusion criteria
Exclusion criteria: 1. Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study, as determined by the Investigator. 2. Disorders of the central nervous system (CNS), psychiatric disorders, behavioral disturbances (e.g., cerebrovascular events, earlier, or current major depression, post-traumatic stress disorder, anxiety, bipolar disorder, severe migraine, Parkinson*s disease, attention deficit hyperactivity disorder). 3. Any personal or familial history (1st degree) of seizures, epilepsy, or other convulsive condition; or previous significant head trauma, or other factors predisposing to seizures. 4. History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs. 5. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, hypofertility, cancer, or cirrhosis. 6. Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates the participation in the study. Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * To characterize mass balance, routes, and rates of elimination of a single oral dose of 150 mg [14C]-labeled RO6889450 * To assess the PK of total drug-related material, RO6889450, and its metabolite(s) as appropriate | — |
Secondary
| Measure | Time frame |
|---|---|
| * To assess the safety and tolerability of single dose administration of RO6889450 * To identify and quantify the metabolic profiles of RO6889450 in plasma, feces and urine, and characterize any major metabolite(s) | — |
Countries
Netherlands
Outcome results
None listed