A Phase 1 interventional study of Sorafenib (Nexavar, BAY43-9006) and Sorafenib (Nexavar, BAY43-9006) in Liver Disease, sponsored by Bayer. Completed at 3 sites in United States. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-02.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
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.
2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 1,322 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Sorafenib (Nexavar, BAY43-9006)
Drug: Sorafenib (Nexavar, BAY43-9006)
Mildly Hepatic Impaired Subjects
Moderately Hepatic Impaired Subjects
Healthy Subjects
PK measurements
Time frame: Day 1-6
Physical Exam
Time frame: Screening, Day 6
Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis
Time frame: Screening Day 1, Day 6
ECG
Time frame: Screening Day 1, Day 6
Vital Signs
Time frame: Screening Day 1, Day 6
Follow up phone call
Time frame: Day 14
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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