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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04166942 | KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment | PHASE1 | COMPLETED | 35 | — | — | Dec 11, 2019 | Jun 6, 2022 | Jul 18, 2022 | 5 | United States |
Area under the concentration-time curve from time 0 to infinity
Area under the concentration-time curve from time 0 to the last measurable concentration
Maximum observed concentration
Time of the observed maximum concentration
Terminal elimination half-life
Time of the last measurable concentration
Apparent total clearance
Apparent volume of distribution
| Arm | Type | Description |
|---|---|---|
| Normal Hepatic Function (Group 1--Control) | EXPERIMENTAL | Matched healthy subjects with normal hepatic function |
| Mild Hepatic Impairment (Group 2) | EXPERIMENTAL | Subjects with mild hepatic impairment based on Child-Pugh Class A score of 5 or 6 |
| Moderate Hepatic Impairment (Group 3) | EXPERIMENTAL | Subjects with moderate hepatic impairment based on Child-Pugh Class B score of 7 to 9 |
| Severe Hepatic Impairment (Group 4) | EXPERIMENTAL | Subjects with severe hepatic impairment based on Child-Pugh Class C score of 10 to 14 |
| Name | Type | Description |
|---|---|---|
| KD025 | DRUG | Single dose of 200 mg KD025 orally |
Inclusion Criteria: For All Subjects: Subjects must satisfy all of the following criteria at the Screening visit, unless otherwise stated: 1. Males or females, of any race, between 18 and 75 years of age, inclusive. 2. Body mass index between 18.0 and 38.0 kg/m\^2, inclusive. 3. Females of non-ch...