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

The Effect of Hepatic Impairment on the Pharmacokinetics of Aleglitazar: A Multiple-centre, Open-label Study Following a Single Oral Dose of Aleglitazar to Subjects With Mild or Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function.

This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched control subjects with normal hepatic function. Subjects will receive a single oral dose of aleglitazar, with assessment of the pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled subject is approximately 6 weeks.

Inclusion Criteria:

• Male and female adults, 18-70 years of age inclusive
• Normal hepatic function or mild to moderate impaired liver function (Child-Pugh class A or B)
• Body mass index (BMI) 18 to 40 kg/m2 inclusive
• Females must be either surgically sterile, postmenopausal, or willing to use two reliable methods of contraception for the duration of the study and started 3 months before study start

Exclusion Criteria:

• For subjects with hepatic impairment: evidence of progressive liver disease within the last 4 weeks, or biliary liver cirrhosis or other causes of hepatic impairment not related to parenchymal disorder and/or disease
• For healthy volunteers: positive test for hepatitis B or C, alcohol intake of more than 14 units per week, or history of clinically significant alcohol or drug abuse
• Acute infection or current malignancy requiring treatment
• History of clinically significant allergic disease or drug hypersensitivity
• Positive test for HIV-1 or HIV-2 at screening
• Participation in a clinical study with an investigational drug or new chemical entity within 2 months prior to screening
• Females who are pregnant or lactating