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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4917838

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042
• Russian Federation
  • Moscow, Russian Federation, 117292
  • Moscow, Russian Federation, 117192

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects	Drug: RO4917838; single oral dose
Experimental: Hepatic impairment	Drug: RO4917838; single oral dose

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP25260; 2010-023641-30 (EudraCT Number)