A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838

Study Overview
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Brief Summary
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This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO4917838


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General: Body mass index (BMI) between 18 and 32 kg/m2 inclusive Healthy Subjects: Adult male or female subjects, 18-70 years of age Hepatically impaired patients: Adult patients, 18-65 years of age Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C) Hepatic impairment should be primary and must not be a complication of an underlying primary disease Exclusion Criteria: General: Pregnant or lactating women Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1 Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator Positive for HIV infection Renal insufficiency Healthy volunteers: History of significant disease, or evidence of disease or condition which could interfere with the study or relapse during or immediately after the study Any history of depressive episodes or treatment with antidepressants Alcohol consumption averaging more than 2 units (16 g) of alcohol for females or 3 units (24 g) for males per day, or positive alcohol breath test at screening/Day -1 Positive for hepatitis B and/or hepatitis C infection Hepatically impaired patients: Evidence of unstable clinically significant disease other than impaired hepatic function, or condition or disease which could interfere with the study or relapse during or immediately after the study Episode of acute depression within the last 6 months or current or previous (within the last 6 months) antidepressant treatment Hepatocellular carcinoma or acute hepatic disease caused by infection or drug toxicity Presence of surgically created or transjugular intrahepatic portal systemic shunts Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchyma disorder and/or disease of the liver

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br> | Drug: RO4917838<br>* single oral dose<br>|
| Experimental: Hepatic impairment<br> | Drug: RO4917838<br>* single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax) |  | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 29 days |