A Phase 1 Study of RO6806127 in Healthy Male Volunteers

Study Overview
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Brief Summary
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This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.

Official Title
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A Single-center, Randomised, Double-blind, Adaptative, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics or RO6806127 in Healthy Male Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Placebo
* Drug: RO6806127


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male participants aged 18 to 45 years, inclusive A BMI between 18 to 30 kg/m2, inclusive Agreement to use highly effective contraception Exclusion Criteria: Clinically significant abnormalities in laboratory test results History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis Significant disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures Use of any prohibited medications and food before study start and during the study Dietary restrictions that would prohibit the consumption of standardized meals

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Single Ascending Dose (SAD)<br>Adaptive model per protocol | Drug: Placebo<br>* Matching placebo, administered orally with approximately 240 mL of buffer<br>Drug: RO6806127<br>* Administered orally with approximately 240 mL of buffer<br>|
| Experimental: Part 2: Food Effect (FE)<br>Fasted versus Fed | Drug: Placebo<br>* Matching placebo, administered orally with approximately 240 mL of buffer<br>Drug: RO6806127<br>* Administered orally with approximately 240 mL of buffer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Up to Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phamacokinetic profile of single-dose oral RO6806127 and its metabolites as appropriate, as assessed by concentrations over time in plasma and urine |  | Up to Day 21 | 
| RO6806127 metabolite concentrations in selected plasma and urine samples |  | Up to Day 21 | 
| Relative bioavailability (food effect): Area under the concentration-time curves [AUC] |  | Up to Day 21 |