Trials / Completed
CompletedNCT04470908
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this study was to determine the effect of the moderate cytochrome P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy males.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | Single oral dose of 320 mg |
| DRUG | Rifabutin | Oral dose of 300 mg once daily |
Timeline
- Start date
- 2020-07-29
- Primary completion
- 2020-11-10
- Completion
- 2020-11-10
- First posted
- 2020-07-14
- Last updated
- 2024-10-26
- Results posted
- 2023-12-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04470908. Inclusion in this directory is not an endorsement.