NCT00829231

Brief Summary

This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

January 23, 2009

Last Update Submit

October 31, 2014

Conditions

Liver Disease

Keywords

Liver disease

Outcome Measures

Primary Outcomes (1)

  • PK measurements

    Day 1-6

Secondary Outcomes (5)

  • Physical Exam

    Screening, Day 6

  • Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis

    Screening Day 1, Day 6

  • ECG

    Screening Day 1, Day 6

  • Vital Signs

    Screening Day 1, Day 6

  • Follow up phone call

    Day 14

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Sorafenib (Nexavar, BAY43-9006)

Arm 2

EXPERIMENTAL
Drug: Sorafenib (Nexavar, BAY43-9006)

Arm 3

EXPERIMENTAL
Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Mildly Hepatic Impaired Subjects

Arm 1

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Miami, Florida, 33014, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

US(3)