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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05753592 | A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants | PHASE1 | COMPLETED | 38 | — | — | Oct 31, 2022 | Dec 17, 2023 | May 6, 2025 | 1 | Hungary |
The maximum (peak) observed blood concentration following multiple-dose administration (mass/volume)
The area under the curve (AUC) from time zero to the end of the dosing interval tau (12 hours) following multiple-dose administration
The area under the curve (AUC) from time zero to the last measurable blood concentration sampling time (Tlast) following multiple-dose administration (mass\*time/volume)
The time to reach maximum (peak) blood concentration following multiple-dose administration (time)
The elimination half-life associated with the terminal slope (lambda\_z) of a semi logarithmic concentration-time curve (time)
| Arm | Type | Description |
|---|---|---|
| Part 1; LOU064 (Remibrutinib) | EXPERIMENTAL | Mild and Moderate HI participants and matching healthy participants |
| Part 2; LOU064 (Remibrutinib) | EXPERIMENTAL | Severe HI participants and matching healthy participants |
| Name | Type | Description |
|---|---|---|
| Part 1; LOU064 (Remibrutinib) | DRUG | 25 mg remibrutinib (5.5 days) |
| Part 2; LOU064 (Remibrutinib) | DRUG | 25 mg remibrutinib (5.5 days) |
Inclusion Criteria: All participants 1. Signed informed consent was obtained prior to participation in the study. 2. Male and non-childbearing potential female\* participants 18 to 70 years of age, inclusive, at Screening. 3. Women of non-childbearing potential were defined as women who were post ...