Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Glasdegib Therapeutic Exposure · 1 trial · 1 indication
Post-dose placebo corrected QTcF intervals from ECG traces following glasdegib dosing.
| Arm | Type | Description |
|---|---|---|
| Glasdegib QT Therapeutic Exposure | EXPERIMENTAL | Randomized sequence of Glasdegib clinical exposure, Placebo and moxifloxacin active control administration. This treatment will be in four separate sequences with four periods per sequence. Each period will be separated by a washout of atleast 6 days. |
| Glasdegib QT Supra-therapeutic Exposure | EXPERIMENTAL | Randomized sequence of glasdegib supra-therapeutic exposure, Placebo and moxifloxacin active control administration. This treatment will be in four separate sequences with four periods per sequence. Each period will be separated by a washout of atleast 6 days. |
| Name | Type | Description |
|---|---|---|
| Glasdegib Therapeutic Exposure | DRUG | Subjects Receive a single 150 mg dose of Glasdegib followed by ECG and PK assessments. |
| Glasdegib Supra-therapeutic Exposure | DRUG | Subjects receive a single 300 mg dose of glasdegib followed by ECG and PK assessments. |
| Positive Control (Moxifloxacin) | DRUG | Subjects will receive a single 400 mg dose of moxifloxacin followed by ECG and PK assessments. |
| Placebo Control | OTHER | Subjects will receive placebo dose followed by ECG and PK assessments. |
Inclusion Criteria: * 1\. Healthy male and/or female subjects of non child bearing potential who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examinat...
Glasdegib Therapeutic Exposure refers to a Phase 1 clinical study evaluating the cardiac repolarization effects of glasdegib in healthy adult volunteers. The trial, NCT03162900, was conducted in Belgium and enrolled 36 participants. Glasdegib is a small molecule developed by Pfizer, Inc. (ticker: PFE).
Glasdegib targets SMO, the Smoothened receptor, and acts as an antagonist. By blocking SMO, glasdegib inhibits the Hedgehog signaling pathway. This mechanism underlies its investigation in clinical studies, including the Phase 1 cardiac repolarization trial NCT03162900.
Glasdegib is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 study NCT03162900 evaluating the drug's effect on cardiac repolarization in healthy subjects.
Glasdegib Therapeutic Exposure is in Phase 1 clinical development. The single registered trial, NCT03162900, has been completed. Glasdegib is an investigational small molecule and is not described as approved for any indication in the available trial record.
Glasdegib has been studied in one completed Phase 1 trial, NCT03162900, titled a Phase 1 study to evaluate the effect of glasdegib on cardiac repolarization in healthy subjects. The trial enrolled 36 participants in Belgium, was randomized, double-blind, and controlled, with no active trials currently listed.