A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants

Study Overview
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Brief Summary
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This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring.

Official Title
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A 2 Part, Randomized, Open-Label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Phase II Tablet Formulation Compared to the Current Phase I Capsule Formulation and the Effect of Food and Taste Assessment on the Phase II Tablet Formulation in Healthy Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: RO7017773 Phase I Capsule
* Drug: RO7017773 Phase II Tablet Unflavored
* Drug: RO7017773 Phase II Tablet Sweetened/Flavored


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Non-smoker for at least six months Healthy, as judged by the Investigator Women of non-childbearing potential (WONCBP) who are not pregnant or lactating Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug Exclusion Criteria History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis) A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions Current or chronic history of liver disease, or known hepatic or biliary abnormalities Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing Participation in an investigational drug or device study within 90 days prior to screening Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies 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: 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>Participants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses. | Drug: RO7017773 Phase I Capsule<br>* Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.<br>Drug: RO7017773 Phase II Tablet Unflavored<br>* Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.<br>|
| Experimental: Part 2<br>Participants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses. | Drug: RO7017773 Phase II Tablet Unflavored<br>* Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.<br>Drug: RO7017773 Phase II Tablet Sweetened/Flavored<br>* Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1) |  | Day 1 to Day 5 | 
| Cmax of RO7017773 (Part 2) |  | Day 1 to Day 5 | 
| Taste Assessment, as Measured by Taste Questionnaire (Part 2) | Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste Assessment, as Measured by Taste Questionnaire (Part 1) | Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste. | Day 1 | 
| Percentage of Participants With Adverse Events (AEs) |  | Baseline through end of study (approximately 6 weeks) |