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 |