Clinical trial NCT01356550: A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)
timeFrame: 22 days
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 29 days
Other outcomes:
Locations:
city: Rennes
country: France
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: