A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT01197911
- Run by
- Hoffmann-La Roche
- People needed
- 38
- Starts
- 2010-09-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2015-12-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify 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 qualify 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
Where it is running
- Study site — Orlando, Florida, United States
- Study site — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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