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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO4917838

Study type

Interventional

Funder types

Industry

Identifiers

NCT01356550

BP25260

2010-023641-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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