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

NCT01356550 | Completed Phase 1

• 2 other identifiers: BP252602010-023641-30
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 3

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

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

  22 days

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  29 days

Study Arms (2)

Healthy subjects

EXPERIMENTAL

Drug: RO4917838

Hepatic impairment

EXPERIMENTAL

Drug: RO4917838

Interventions

RO4917838 DRUG

single oral dose

Healthy subjects; Hepatic impairment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Rennes, 35042, France

Location

Unknown Facility

Moscow, 117192, Russia

Location

Unknown Facility

Moscow, 117292, Russia

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 19, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

RU (2); FR (1)