Healthy adults
Conditions
Interventions
investigational material(s)
Generic name etc : RO6889450
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administration for
Sponsors
Chugai Pharmaceutical Co., Ltd.
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese man who is 20 to 45 years of age at the time of informed consent. (2) Body mass index (weight [kg]/[height {m}]2) of 18 to <=30 kg/m2 at screening. (3) Consent by partner of childbearing potential to use a contraceptive method (hormonal contraceptives, intrauterine device, barrier method [excluding rhythm method], etc.) until 90 days after last-administration. (4) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) 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). (2) Positive family history of psychosis or mood disorders up to first degree relative. (3) Participation in a clinical study and treatment with an IMP (including placebo) within 4 months (or 5 half-lives of the other IMP, whichever is longer) before enrollment. (4) Use of prescription drugs within 2 weeks before enrollment. However, subjects will be permitted to use products that do not result in systemic exposure and would therefore have no effect even if they were used, such as topical antiseptics and eye-drops.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety observation | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics - | — |
Countries
Japan
Outcome results
None listed