A Study to Assess the Effect of Hepatic Function on the P... | NCT01187186

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

NCT01187186

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 7, 2010Estimated

Enrollment

16Actual

Phase

Phase 1

Conditions

Liver Disease

Interventions

ASP1941

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Aug 20, 2010

First Submission Date that Met QC Criteria

Aug 20, 2010

First Posted Date

Aug 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2010

Last Update Posted Date

Oct 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moderate Hepatic Impairment	Experimental	Subjects with Moderate Hepatic Impairment	Drug: ASP1941
Normal Hepatic Function	Experimental	Subjects with Normal Hepatic Function	Drug: ASP1941

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1941	Drug	oral	Moderate Hepatic Impairment Normal Hepatic Function

Measure	Description	Time Frame
Pharmacokinetic variables used to assess the effect of hepatic function through analysis of blood samples		7 days following study drug administration

Measure	Description	Time Frame
Pharmacokinetic variables used to assess the effect of hepatic impairment through analysis of blood and urine samples		7 days following study drug administration

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided