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: October 6, 2014
Last verified: October 2014
  Purpose

This open-label, single-dose, parallel group study will assess the pharmacokinet ics and safety of RO4917838 in healthy volunteers and patients with mild, modera te or severe chronic hepatic impairment. Patients and healthy volunteers will re ceive 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 16, 2014