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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07198087 | A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants | PHASE1 | ACTIVE NOT_RECRUITING | 40 | — | — | Oct 1, 2025 | Dec 31, 2026 | Apr 16, 2026 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Tirabrutinib (Mild Hepatic Impairment) | EXPERIMENTAL | Participants received a single dose of Tirabrutinib 80 mg administered orally on Day 1. |
| Tirabrutinib (Moderate Hepatic Impairment) | EXPERIMENTAL | Participants received a single dose of Tirabrutinib 80 mg administered orally on Day 1. |
| Tirabrutinib (Severe Hepatic Impairment) | EXPERIMENTAL | Participants received a single dose of Tirabrutinib 80 mg administered orally on Day 1. |
| Tirabrutinib (Normal Hepatic Function) | EXPERIMENTAL | Participants received a single dose of Tirabrutinib 80 mg administered orally on Day 1. |
| Name | Type | Description |
|---|---|---|
| Tirabrutinib | DRUG | Administered orally |
Inclusion Criteria: * Male or female participants, age 18 to 75, inclusive, at the time of informed consent. * BMI between 18 and 40 kg/m2, inclusive, at Screening. * Continuous non-smokers or smokers who smoke 20 cigarettes or fewer per day. * Willingness and ability to swallow study intervention ...