Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513

Study Overview
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Brief Summary
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This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.

Official Title
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A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain alpha5-Containing GABAA Receptors of Ro7017773 Using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: RO7017773
* Other: [11C] Ro15-4513


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 chemisty, serology, and urinalysis), as judged by the Investigator. Males 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 CNS infections Clinically significant abnormal finding from the MRI performed after the initial screening examination Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

Ages Eligible for Study
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Minimum Age: 23 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>The first two participants of the first cohort are anticipated to receive a single dose of RO7017773 orally. The doses to be tested in the subsequent cohorts of participants will be determined by review of PET scan, PK, and safety results from the previous dose level. | Drug: RO7017773<br>* RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.<br>Other: [11C] Ro15-4513<br>* At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773 |  | Baseline up to 48 hours (hrs) | 
| Plasma Concentrations of RO7017773 |  | Baseline up to 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) |  | From treatment initiation until 14 days after the last dose of study treatment. |