Trials / Completed
CompletedNCT03465059
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Zanubrutinib (BGB-3111) in Subjects With Varying Degrees of Hepatic Impairment
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | A single oral dose of 80 mg Zanubrutinib will be administered. |
Timeline
- Start date
- 2018-05-30
- Primary completion
- 2018-10-19
- Completion
- 2018-10-19
- First posted
- 2018-03-14
- Last updated
- 2020-04-24
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03465059. Inclusion in this directory is not an endorsement.