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...
Glasdegib single dose in normal healthy subjects refers to a Phase 1 clinical study evaluating a single 100 mg oral dose of glasdegib in healthy adult volunteers. The trial was designed to assess the drug's behavior in participants with renal impairment compared with normal renal function. It was developed by Pfizer and has been completed.
It is used to study how a single 100 mg dose of glasdegib behaves in people with renal impairment. The Phase 1 trial enrolled 18 healthy volunteers, including participants with impaired kidney function, to characterize the drug's pharmacokinetics in that setting. Glasdegib is a small molecule SMO antagonist.
Glasdegib targets SMO, the Smoothened receptor in the Hedgehog signaling pathway. It acts as an SMO antagonist, meaning it blocks signaling through that receptor. This mechanism underlies its investigation in the renal impairment study of a single 100 mg dose in healthy subjects.
Pfizer, Inc. (ticker PFE) is the developer of glasdegib, including the single 100 mg dose studied in normal healthy subjects. Pfizer sponsored the Phase 1 renal impairment trial, which was conducted in the United States and has been completed.
Glasdegib single dose in normal healthy subjects is in Phase 1. The single trial, NCT03596567, titled Glasdegib Renal Impairment Study, is completed and enrolled 18 participants. It was a randomized, controlled study without double blinding, and it included healthy volunteers aged 18 years and older.
Glasdegib single dose in normal healthy subjects was evaluated in one clinical trial, NCT03596567, called the Glasdegib Renal Impairment Study. The Phase 1 trial enrolled 18 participants in the United States, was randomized and controlled, and has been completed.