Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glasdegib single dose in normal healthy subjects · 1 trial · 1 indication
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
| Arm | Type | Description |
|---|---|---|
| Normal Renal Function Group | EXPERIMENTAL | Subjects with estimated glomerular filtration rate (eGFR) of =\> 90 ml/min |
| Moderate Renal Impairment Group | EXPERIMENTAL | Subjects with estimated glomerular filtration rate (eGFR) of =\> 30ml/min and \< 60 ml/min |
| Severe Renal Impairment Group | EXPERIMENTAL | Subjects with estimated glomerular filtration rate (eGFR) of \< 30 ml/min and not requiring dialysis |
| Name | Type | Description |
|---|---|---|
| Glasdegib single 100 mg dose in normal healthy subjects | DRUG | A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow -up. |
| Glasdegib single 100 mg dose in moderate renal impairment subjects | DRUG | A single dose of 100 mg glasdegib tablet will be administered to subjects with moderate renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up. |
| Glasdegib single 100 mg dose in severe renal impairment subjects | DRUG | A single dose of 100 mg glasdegib tablet will be administered to subjects with severe renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up. |
Inclusion Criteria: 1. Healthy female subjects of non child bearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 75 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical ex...