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Clinical Trials/NCT01356550
NCT01356550CompletedPhase 1

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

Hoffmann-La Roche0 sites35 target enrollmentStarted: June 2011Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
35
Primary Endpoint
Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Healthy subjects

Experimental

Intervention: RO4917838 (Drug)

Hepatic impairment

Experimental

Intervention: RO4917838 (Drug)

Outcomes

Primary Outcomes

Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)

Time Frame: 22 days

Secondary Outcomes

  • Safety: Incidence of adverse events(29 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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