A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

Official Title
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A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: RO7017773
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis) as judged by the Investigator. Male and women of non-childbearing potential (WONCBP) Exclusion Criteria History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis) History of clinically significant hypersensitivity or allergic reactions Abnormal blood pressure Abnormal pulse rate History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease Current or chronic history of liver disease, or known hepatic or biliary abnormalities Positive test for drugs of abuse or alcohol Evidence of human immunodeficiency virus (HIV) infection Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result at screening or within 3 months prior to starting study treatment Participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO7017773<br>Single dose of RO7017773 | Drug: RO7017773<br>* Single doses of RO7017773<br>|
| Experimental: RO7017773 and Itraconazole<br>Single dose of RO7017773 and multiple doses of itraconazole | Drug: RO7017773<br>* Single doses of RO7017773<br>Drug: Itraconazole<br>* Multiple doses of Itraconazole<br>* Other names: Sporanox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Concentration (Cmax) of RO7017773 in Plasma |  | Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) |  | 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. | From screening visit through Period 2 Day 11 | 
| Cmax of Itraconazole in Plasma |  | Period 2 |