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

NCT ID: NCT01197911

Last Updated: 2015-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Mild impairment

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

single oral dose

Moderate impairment

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

single oral dose

Normal HF

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

single oral dose

Interventions

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aleglitazar

single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Orlando, Florida, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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BP25240

Identifier Type: -

Identifier Source: org_study_id