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 is an investigational small molecule being studied in healthy volunteers. It is being developed by Pfizer, Inc. (PFE). The drug is currently in Phase 1 clinical development, with one completed trial involving 36 participants.
Glasdegib Therapeutic Exposure is being studied in healthy volunteers. The completed Phase 1 trial evaluated the effect of the drug on cardiac repolarization in healthy subjects. It is not being studied for a specific disease indication at this time.
Glasdegib Therapeutic Exposure is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company sponsored the Phase 1 clinical trial of the drug in healthy volunteers.
Glasdegib Therapeutic Exposure is in Phase 1 clinical development. The single Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities.
Glasdegib Therapeutic Exposure has one completed clinical trial, NCT03162900, titled "A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects." The trial enrolled 36 participants in Belgium and was a randomized, double-blind, controlled study.
Glasdegib Therapeutic Exposure is a formulation of glasdegib, a small molecule. The Phase 1 trial evaluated the effect of glasdegib on cardiac repolarization in healthy subjects. The drug is being developed by Pfizer.