function. subjects with RRMM and impaired renal CC-4047-MM-008 function. Protocol available A Phase I, open-label, two-part study Use in patients with Primary Objectives: Q1 2016 (Final report) to evaluate the pharmacokinetics of hepatic impairment Part 1: To evaluate the effect of severe pomalidomide (cc-4047) in hepatic impairment on the hepatically impaired male subjects. pharmacokinetics (PK) of a single oral CC-4047-CP-009. dose of pomalidomide in male subjects. Protocol available. Part 2: To evaluate the effect of moderate and mild hepatic impairment on the PK of a single oral dose of pomalidomide in male subjects. Secondary Objectives: To evaluate the effect of hepatic impairment on the safety of a single oral dose of pomalidomide in male subjects. In trial assessment of pomalidomide Interactions with drugs Conclusion: Q3 2013 (Final Report) as an inhibitor of P-glycoprotein affecting and The efflux ratio of digoxin was not using Caco-2 cells. metabolised by reduced in the presence of pomalidomide CC-4047-DMPK-1586 CYP1A2, 3A4/5 and indicating it is not an inhibitor of P-gp in Final report available vitro.
function. CC-4047-MM-008 Protocol available subjects with RRMM and impaired renal function. A Phase I, open-label, two-part study to evaluate the pharmacokinetics of pomalidomide (cc-4047) in hepatically impaired male subjects. CC-4047-CP-009. Protocol available. Use in patients with hepatic impairment Primary Objectives: Part 1: To evaluate the effect of severe hepatic impairment on the pharmacokinetics (PK) of a single oral dose of pomalidomide in male subjects. Part 2: To evaluate the effect of moderate and mild hepatic impairment on the PK of a single oral dose of pomalidomide in male subjects. Secondary Objectives: To evaluate the effect of hepatic impairment on the safety of a single oral dose of pomalidomide in male subjects. Q1 2016 (Final report) In assessment of pomalidomide as an inhibitor of P-glycoprotein using Caco-2 cells. CC-4047-DMPK-1586 Final report available Interactions with drugs affecting and metabolised by CYP1A2, 3A4/5 and Conclusion: The efflux ratio of digoxin was not reduced in the presence of pomalidomide indicating it is not an inhibitor of P-gp in vitro. Q3 2013 (Final Report) trial
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