Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03162900 | A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects | PHASE1 | COMPLETED | 36 | — | — | Jun 9, 2017 | Oct 16, 2017 | Sep 6, 2019 | 1 | Belgium |
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...