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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01356550
First received: May 18, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: RO4917838
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax) [ Time Frame: 22 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy subjects Drug: RO4917838
single oral dose
Experimental: Hepatic impairment Drug: RO4917838
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356550

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01356550     History of Changes
Other Study ID Numbers: BP25260, 2010-023641-30
Study First Received: May 18, 2011
Last Updated: April 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 17, 2014