Status:
COMPLETED
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01197911
Start Date
September 1 2010
End Date
August 1 2011
Last Update
December 24 2015
Active Locations (2)
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1
Orlando, Florida, United States, 32809
2
Knoxville, Tennessee, United States, 37920