A Phase 1 interventional study of BGB-43395 and Midazolam in Healthy Adult Participants, sponsored by BeOne Medicines. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by BeOne Medicines · Phase 1, Interventional, and Treatment
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
BGB-43395 is a drug that blocks a protein called cyclin-dependent kinase 4 (CDK4). CDK4 is a type of protein that regulates cell growth and division and can drive uncontrolled tumor cell growth. BGB-43395 is being developed for the treatment of patients with advanced solid tumors.
The purpose of this study is to test whether BGB-43395 has any significant drug interactions with midazolam, celecoxib, dabigatran, and rosuvastatin. The main goal of the study is to test whether BGB-43395 affects how other drugs are processed by the body.
This study consists of 2 parts. In Part 1, healthy participants will receive midazolam and celecoxib alone and with BGB-43395. In Part 2, healthy participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
The study will enroll approximately 24 healthy adult participants. The overall time to participate in this study is up to 7 weeks. Blood samples will be taken at specific time points, as well as vital signs and electrocardiograms.
BeOne Medicines is the lead sponsor of 68 studies on the registry; 48 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Note: Other protocol-defined inclusion and exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive midazolam and celecoxib alone and with BGB-43395.
Drug: BGB-43395 · Drug: Midazolam · Drug: Celecoxib
Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.
Drug: BGB-43395 · Drug: Dabigatran etexilate · Drug: Rosuvastatin
Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin.
Time frame: 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.
Time frame: Samples will be collected predose and at specified timepoints, up to 10 days
Maximum Observed Concentration (Cmax)
Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
Time frame: 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.
Time frame: Samples will be collected predose and at specified timepoints, up to 10 days
Number of Participants With Adverse Events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), clinical laboratory abnormalities, 12-lead electrocardiogram, vital signs measurement, and physical examination findings.
Time frame: From first dose up to 17 days
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See plan description
Access criteria: See plan description
Data sharing details ↗ · beonemedicines.com
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 1 month after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: CDK4 Inhibitor BGB-43395