Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
