Healthy Adult ParticipantsPhase 1NCT07820891
A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395
A Phase 1 study testing BGB-43395, Midazolam and Celecoxib in people with Healthy Adult Participants, run by BeOne Medicines at 1 site in United States.
Trial summary
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- BGB-43395, Midazolam and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 22 Nov 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit
Dallas, Texas, 75247
About this study
Official title: 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
This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.
Read the detailed description
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.
- Conditions
- Healthy Adult Participants
- Being tested
- BGB-43395, Midazolam, Celecoxib, Dabigatran etexilate, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-43395Drug
Administered orally
MidazolamDrug
Administered orally
CelecoxibDrug
Administered orally
Dabigatran etexilateDrug
Administered orally
RosuvastatinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants will receive midazolam and celecoxib alone and with BGB-43395. Receives: Drug: BGB-43395; Drug: Midazolam; Drug: Celecoxib |
| Part 2 | Experimental | Participants will receive dabigatran and rosuvastatin alone and with BGB-43395. Receives: Drug: BGB-43395; Drug: Dabigatran etexilate; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf)
AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin.
Measured: 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.
Measured: Samples will be collected predose and at specified timepoints, up to 10 days
Maximum Observed Concentration (Cmax)
Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
Measured: 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.
Measured: Samples will be collected predose and at specified timepoints, up to 10 days
Secondary outcomes (1)
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.
Measured: From first dose up to 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start25 Sep 2026
- Primary completion22 Nov 2026 (estimated)
- Study completion22 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820891
- Sponsor's protocol ID
- BGB-43395-104
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.