BGB-43395 for Healthy Subjects
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's possible that taking medications could affect eligibility. Please consult with the trial organizers for more details.
What is the purpose of this trial?
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.
Research Team
Study Director Study Director
Principal Investigator
BeiGene
Eligibility Criteria
This trial is for healthy adults aged 18-65 with a BMI between 18.0 and 32.0 kg/m2. Participants must be in good health without significant medical history findings and willing to follow study rules.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive a single dose of each formulation of BGB-43395 in separate periods to determine relative bioavailability
Treatment Part 2
Participants receive three doses of the selected formulation of BGB-43395 under different dietary conditions to assess food effect
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BGB-43395
Find a Clinic Near You
Who Is Running the Clinical Trial?
BeiGene
Lead Sponsor