Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGRO4917838
single oral dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax) | 22 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | 29 days |
Countries
France, Russia
Outcome results
None listed