NCT06543043

A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax (BGB-11417) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.

Conditions

• Not Determined

Interventions

Type	Name	Description
DRUG	Phenytoin	Administered orally.
DRUG	Itraconazole	Administered orally.
DRUG	sonrotoclax	Administered orally.

Timeline

• Start date: 2024-08-19
• Primary completion: 2024-10-08
• Completion: 2024-11-07
• First posted: 2024-08-07
• Last updated: 2024-11-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study