Clinical Trial: NCT07198087
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Ono Pharmaceutical Co., Ltd. |
| Information Provided By: | Ono Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-06-26 |
Study Overview
Brief Summary
A study to investigate the pharmacokinetics of tirabrutinib in participants with mild, moderate, and severe hepatic impairment compared to healthy participants
Official Title
A Phase 1, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
Conditions
Primary Central Nervous System Lymphoma (PCNSL)
Intervention / Treatment
- Drug: Tirabrutinib
Other Study ID Numbers
- ONO-4059-16
Start Date (Actual)
2025-10-01
Primary Completion Date (Actual)
2026-04-09
Study Completion Date (Actual)
2026-04-20
Enrollment (Actual)
40
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Ono Pharmaceutical Co., Ltd. |
| Information Provided By: | Ono Pharmaceutical Co., Ltd. |
| Last Update Posted: | 2026-06-26 |
Study Overview
Brief Summary
A study to investigate the pharmacokinetics of tirabrutinib in participants with mild, moderate, and severe hepatic impairment compared to healthy participants
Official Title
A Phase 1, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
Conditions
Primary Central Nervous System Lymphoma (PCNSL)
Intervention / Treatment
- Drug: Tirabrutinib
Other Study ID Numbers
- ONO-4059-16
Start Date (Actual)
2025-10-01
Primary Completion Date (Actual)
2026-04-09
Study Completion Date (Actual)
2026-04-20
Enrollment (Actual)
40
Study Type
Interventional
Phase
Phase 1