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

Healthy Volunteer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356550
• Other study ID #: BP25260
• Secondary ID: 2010-023641-30
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917838
single oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

France,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of RO4917838 (area under the concentration-time curve, Cmax)		22 days	No
Secondary	Safety: Incidence of adverse events		29 days	No