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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06388616 | Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone | PHASE1 | COMPLETED | 30 | — | — | May 2, 2024 | Sep 5, 2024 | Nov 12, 2024 | 3 | United States |
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
To compare the PK of a single oral dose of balcinrenone in participants with mild and moderate hepatic impairment to those with normal hepatic function
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Subjects with Mild Impairment will receive a single oral dose of balcinrenone under fasted conditions. |
| Group 2 | EXPERIMENTAL | Subjects with Moderate Impairment will receive a single oral dose of balcinrenone under fasted conditions. |
| Group 3 | EXPERIMENTAL | Healthy participants will receive a single oral dose of balcinrenone under fasted conditions. |
| Name | Type | Description |
|---|---|---|
| Balcinrenone | DRUG | 50 mg, Immediate release capsule to be taken orally. |
Inclusion Criteria: \- Participant must be 18 to 79 years of age, inclusive, at the time of signing the informed consent. For participant with hepatic impairment: * Participant must have a diagnosis of chronic (≥ 6 months) and stable hepatic impairment Child Pugh Class A or B (eg, no clinically s...