A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | September 2010 |
| End Date: | August 2011 |
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.
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
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