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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03627754 | A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib | PHASE1 | COMPLETED | 24 | — | — | Nov 5, 2018 | Apr 11, 2019 | May 6, 2019 | 3 | United States |
PK parameter of glasdegib to be calculated from the plasma concentration-time data
PK parameter of glasdegib to be calculated from the plasma concentration-time data
| Arm | Type | Description |
|---|---|---|
| Moderate Hepatic Impairment Group | EXPERIMENTAL | Subjects with Child-Pugh Classification B (score 7-9) |
| Severe Hepatic Impairment Group | EXPERIMENTAL | Subjects with Child-Pugh Classification C (score 10-15) |
| Normal Hepatic Function Group | EXPERIMENTAL | Healthy subjects with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Glasdegib 100 mg single oral dose | 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. |
Inclusion Criteria: 1. Healthy or hepatically impaired 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. 2. Female subjects of nonchildbearing potential must meet at least 1 of the following criteri...