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

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ClinicalTrials.gov Identifier: NCT01356550
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO4917838 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : June 2011
Primary Completion Date : October 2011
Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: Healthy subjects Drug: RO4917838
single oral dose
Experimental: Hepatic impairment Drug: RO4917838
single oral dose

Primary Outcome Measures :
  1. Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax) [ Time Frame: 22 days ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 29 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  • 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:


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356550

Rennes, France, 35042
Russian Federation
Moscow, Russian Federation, 117192
Moscow, Russian Federation, 117292
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01356550     History of Changes
Other Study ID Numbers: BP25260
2010-023641-30 ( EudraCT Number )
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016