A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395
A Phase 1, Open-label, Fixed-sequence Trial in Healthy Participants to Assess the Drug Interaction Potential of BGB-43395 With A Drug Cocktail Representative for CYP3A4, CYP2C9, P-gp, and BCRP Substrates
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2026
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2026
CompletedFirst Posted
Study publicly available on registry
September 15, 2026
CompletedStudy Start
First participant enrolled
September 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 22, 2026
September 15, 2026
September 1, 2026
2 months
September 10, 2026
September 10, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin.
Samples will be collected predose and at specified timepoints, up to 10 days
Area Under the Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast)
AUC0-tlast for midazolam, celecoxib, dabigatran, and rosuvastatin.
Samples will be collected predose and at specified timepoints, up to 10 days
Maximum Observed Concentration (Cmax)
Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
Samples will be collected predose and at specified timepoints, up to 10 days
Time to Reach Maximum Observed Concentration (Tmax)
Tmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
Samples will be collected predose and at specified timepoints, up to 10 days
Secondary Outcomes (1)
Number of Participants With Adverse Events (AEs)
From first dose up to 17 days
Study Arms (2)
Part 1
EXPERIMENTALParticipants will receive midazolam and celecoxib alone and with BGB-43395.
Part 2
EXPERIMENTALParticipants will receive dabigatran and rosuvastatin alone and with BGB-43395.
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index between 18.0 and 32.0 kg/m\^2, inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram and vital signs measurements, and clinical laboratory assessments.
- Participants must not be pregnant or lactating and must agree to use contraception.
You may not qualify if:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, or pulse rate \>100 or \<40 beats per minute.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
- Fortreacollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2026
First Posted
September 15, 2026
Study Start
September 24, 2026
Primary Completion (Estimated)
November 22, 2026
Study Completion (Estimated)
November 22, 2026
Last Updated
September 15, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.