NCT06761898

A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants

A Phase 1, Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-43395 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	BGB-43395	Administered orally as solid dispersion tablet or salt tablet
DRUG	BGB-43395	Administered orally as solid dispersion tablet or salt tablet

Timeline

• Start date: 2025-01-14
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2025-01-07
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study