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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: aleglitazar

Study type

Interventional

Funder types

Industry

Identifiers

NCT01197911

BP25240

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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