A Phase I Single-Ascending Dose and Multiple-Ascending Dose Study of RO6889450 in Healthy Japanese Male
- Conditions
- Healthy adults
- Registration Number
- JPRN-jRCT2080224516
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 64
(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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>observation
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>-