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A Study to Assess the Effect of Hepatic Function on the Pharmacokinetics and Safety of ASP1941

NCT ID: NCT01187186

Last Updated: 2010-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics (PK) and safety following oral administration of ASP1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the Child-Pugh Classification (CPC).

Detailed Description

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Study drug will be orally administered on Day 1. Subjects will be admitted to the clinic until completion of clinic discharge procedures on Day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.

Conditions

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Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Moderate Hepatic Impairment

Subjects with Moderate Hepatic Impairment

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

Normal Hepatic Function

Subjects with Normal Hepatic Function

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

Interventions

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ASP1941

oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with Moderate Hepatic Impairment

* Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
* Weights at least 45 kg
* Body mass index between 18 and 34 kg/m2
* Meets criteria for moderate hepatic impairment defined by Child-Pugh method
* Subjects with Normal Hepatic Function

* Agrees to practice highly effective birth control until 7 days post dose. If female, two years post-menopausal, surgically sterile, and not pregnant or lactating
* Weights at least 45 kg
* Body mass index between 18 and 34 kg/m2
* Must have normal hepatic function defined by Child-Pugh method

Exclusion Criteria

* Subjects with Moderate Hepatic Impairment

* Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal /gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation.
* Has severe or moderate renal dysfunction
* Known to be human immunodeficiency virus (HIV) positive
* Has clinically significant history or presence of illness, malignancy or immunodeficiency
* Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
* Has history of alcoholism or drug/chemical/substance abuse within past 2 years
* Subjects with Normal Hepatic Function

* Has severe or moderate renal dysfunction
* Known to be human immunodeficiency virus (HIV) positive
* Has clinically significant history or presence of illness, malignancy or immunodeficiency
* Has had a blood transfusion or donated / lost 450 mL of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in
* Has history of alcoholism or drug/chemical/substance abuse within past 2 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Global Development

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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1941-CL-0063

Identifier Type: -

Identifier Source: org_study_id