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Table 2 Selected trials of oncology drugs in healthy volunteers.

From: Reviewing the role of healthy volunteer studies in drug development

NCT number Treatment Target/MOA Study design Outcomes Study population Enrolled (N)
Completed clinical trials
 NCT00658554 ARQ 197 c-MET inhibitor Randomized, open-label, crossover PK, safety Healthy volunteers 24
 NCT02474537 INC280 (capmatinib) c-MET inhibitor Open-label, parallel-group, two-staged, single-dose PK, safety Subjects with impaired hepatic function; healthy subjects with normal hepatic function 31
 NCT03154086 GSK3352589 RET growth factor receptor TKI Randomized, double-blind, crossover, placebo-controlled, single- and repeat-dose escalation Safety, PK Healthy volunteers 59
 NCT03192111 Entinostat HDAC inhibitor Open-label, parallel-cohort, single-dose PK, safety, tolerability Adults subjects with mild, moderate, severe renal impairment; healthy volunteers 40
 NCT00418626 Nilotinib (AMN107) TKI Open-label, single-dose, PK, impact on hepatic function Subjects with impaired hepatic function; healthy subjects with normal hepatic function 27
 NCT02388620 LEE011 (ribociclib) CDK4/6 inhibitor Open-label, parallel-cohort, single-dose PK, safety Subjects with impaired hepatic function; healthy subjects with normal hepatic function 30
 NCT01764776 LDE225 (sonidegib) Smo antagonist Open-label, single-dose PK, safety Subjects with impaired hepatic function; healthy subjects with normal hepatic function 33
 NCT02050815 MEK162 (binimetinib) MEK inhibitor Open-label, single-dose PK, safety Subjects with impaired hepatic function; healthy subjects with normal hepatic function 27
 NCT02621047 Alectinib ALK inhibitor Open-label, single-dose, parallel assignment Effect of hepatic impairment on PK Subjects with hepatic impairment; healthy subjects with normal hepatic function 28
 NCT01901133 MDV3100 (enzalutamide) AR antagonist Open-label, single-dose, parallel assignment PK, safety Male subjects with mild or moderate hepatic impairment; male subjects with normal hepatic function 33
Ongoing clinical trials
 NCT02922946 (not yet recruiting) Entinostat HDAC inhibitor Open-label, randomized, single-dose, crossover Effect of food on PK Healthy subjects 48
 NCT02431481 (ongoing) LEE011 (ribociclib) CDK4/6 inhibitor Open-label, parallel-group, single-dose PK, safety Subjects with varying degrees of impaired renal function; healthy volunteers with normal renal function 64
 NCT02852239 (ongoing) Dabrafenib BRAF inhibitor Open-label, single-dose PK, safety Subjects with impaired renal function; healthy subjects with normal renal function ~ 32
 NCT02852239 (ongoing) Dabrafenib BRAF inhibitor Open-label, single-dose PK, safety Subjects with impaired hepatic function; healthy subjects with normal hepatic function ~ 32
  1. ALK, anaplastic lymphoma kinase; AR, androgen receptor; BRAF, v-raf murine sarcoma viral oncogene homolog B1; CDK4/6, cyclin-dependent kinases 4 and 6; HDAC, histone deacetylase; MOA, mechanism of action; PK, pharmacokinetics; TKI, tyrosine kinase inhibitor