Healthy participants
Conditions
Interventions
Each cohort 1-3 (n=12 in each cohort) was devided into Subcohort A(n=4) and Subcohort B (n=8).
- Subcohort A (1-A,2-A,3-A) :
- Single dose of Investigational product (n=3 in each cohort))
- Single
Sponsors
Sinmyo Satoru
Eligibility
Inclusion criteria
Inclusion criteria: - Written informed consent must be obtained before any assessment is performed. - Healthy Japanese males and females of non-child bearing potential aged 18 to 55 years of age, inclusive, and in good health as determined by past medical history and screening and baseline assessments. - Participants must weigh at least 40.0 kg and at maximum 100.0 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2, inclusive.
Exclusion criteria
Exclusion criteria: - A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities: - PR > 200 msec - QRS complex > 120 msec - QTcF > 450 msec (males) - QTcF > 460 msec (females) - History of neurological disorders - Use of any prescription drugs, herbal supplements, within 4 weeks or 5-half-lives whichever is longer prior to initial dosing, and over-the-counter (OTC) medication, dietary supplements (vitamins included) within two weeks or 5-half-lives whichever is longer prior to initial dosing. - Donation or loss of 400 mL or more of blood within 16 weeks prior to first dosing - Any surgical or medical condition which might significantly alter the distribution, metabolism, or excretion of drugs, or which may jeopardize the participant in case of participation in the study. - Participants with spinal deformities, in the opinion of the investigator, that would preclude the subject participation for CSF collection during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events, vital signs, ECG data, laboratory assessments,Columbia Suicide Severity Rating Scale (C-SSRS), Profile of Mood States (POMS), and local tolerability | — |
Contacts
Public ContactSatoru Sinmyo
Novartis Pharma. K.K.
Outcome results
None listed