The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Single doses of RO7017773
Multiple doses of Itraconazole
BIOTRIAL
Rennes, France
Maximum Concentration (Cmax) of RO7017773 in Plasma
Time frame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)
Percentage of Participants With Adverse Events (AEs)
Time frame: 12 weeks
Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present.
Time frame: From screening visit through Period 2 Day 11
Cmax of Itraconazole in Plasma
Time frame: Period 2
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