gdc-0973 and Liver-Diseases

gdc-0973 has been researched along with Liver-Diseases* in 1 studies

Trials

1 trial(s) available for gdc-0973 and Liver-Diseases

Article	Year
Effect of Hepatic Impairment on Cobimetinib Pharmacokinetics: The Complex Interplay Between Physiological Changes and Drug Characteristics. Clinical pharmacology in drug development, 2021, Volume: 10, Issue:2 Cobimetinib is a kinase inhibitor indicated for use in combination with vemurafenib for treatment of unresectable/metastatic melanoma with specific BRAF mutations. Cobimetinib is extensively metabolized in liver; thus, patients with hepatic impairment (HI) might have increased cobimetinib exposure. In this study, we investigated the impact of HI on the pharmacokinetics (PK) and safety of cobimetinib. Subjects with normal hepatic function and mild to severe HI were enrolled. All subjects received a single oral dose of 10 mg cobimetinib, and serial blood samples were collected at specified times. Cobimetinib PK in subjects with mild and moderate HI was similar to that in those with normal liver function. However, subjects with severe HI, on average, showed ∼30% lower total AUC Topics: Adult; Aged; Antineoplastic Agents; Area Under Curve; Azetidines; Female; Humans; Liver Diseases; Male; Middle Aged; Piperidines; Protein Kinase Inhibitors; Severity of Illness Index	2021

Article

Year

Effect of Hepatic Impairment on Cobimetinib Pharmacokinetics: The Complex Interplay Between Physiological Changes and Drug Characteristics.

Clinical pharmacology in drug development, 2021, Volume: 10, Issue:2

Cobimetinib is a kinase inhibitor indicated for use in combination with vemurafenib for treatment of unresectable/metastatic melanoma with specific BRAF mutations. Cobimetinib is extensively metabolized in liver; thus, patients with hepatic impairment (HI) might have increased cobimetinib exposure. In this study, we investigated the impact of HI on the pharmacokinetics (PK) and safety of cobimetinib. Subjects with normal hepatic function and mild to severe HI were enrolled. All subjects received a single oral dose of 10 mg cobimetinib, and serial blood samples were collected at specified times. Cobimetinib PK in subjects with mild and moderate HI was similar to that in those with normal liver function. However, subjects with severe HI, on average, showed ∼30% lower total AUC

Topics: Adult; Aged; Antineoplastic Agents; Area Under Curve; Azetidines; Female; Humans; Liver Diseases; Male; Middle Aged; Piperidines; Protein Kinase Inhibitors; Severity of Illness Index

2021