A Study on The Effect of Multiple Doses of Activated Charcoal on The Pharmacokinetics of a Single Dose of RO4995819

Study Overview
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Brief Summary
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This open-label, two period crossover study will evaluate the effect of multiple doses of activated charcoal on the pharmacokinetics of a single oral dose of RO4995819 in healthy volunteers. Each enrolled subject will receive two single oral doses of RO4995819 separated by a wash-out period of up to 9 weeks. In period 1, subjects will receive concomitantly with the single dose of RO4995819 multiple oral doses of activated charcoal until Day 7. In period 2, only a single dose of RO4995819 but no activated charcoal will be administered.

Official Title
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A Single-Center, Open-Label, Two-Period Crossover Study to Investigate the Effect of Multiple Doses of Activated Charcoal on the Pharmacokinetics of a Single Oral Dose of RO4995819 in Healthy Subjects.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO4995819
* Drug: activated charcoal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects, 18 to 65 years of age, inclusive Body mass index (BMI) 18 to 30 kg/m2 inclusive All subjects must agree to use a barrier method (e.g. condom) throughout the study and for up to 5 months after the last dose of study drug Significant past or present disorders of the central nervous system, psychiatric disorders or behavioral disturbances. Exclusion Criteria: Any suspicion or history of alcohol abuse and/or consumption of other drugs of abuse Positive for hepatitis B, hepatitis C, or HIV 1 or HIV 2 Participation in an investigational drug or device study within 3 months prior to first administration of the study drug Any confirmed allergic reaction against any drug or multiple allergies Dietary restrictions that would prohibit the consumption of standardized meals Positive cotinine test and/or any use of nicotine containing products Clinically relevant history of constipation or bowel disorder Known intolerability to activated charcoal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: RO4995819<br>* single oral dose<br>Drug: activated charcoal<br>* orally 3 times daily, Days 1-7<br>|
| Active Comparator: 2<br> | Drug: RO4995819<br>* single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C max: maximum observed plasma concentration |  | 18 weeks | 
| T max: time of maximum observed plasma concentration |  | 18 weeks | 
| T1/2: apparent terminal half-life |  | 18 weeks | 
| AUC: area under the plasma concentration-time curve |  | 18 weeks |