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

This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants
• Intervention / Treatment: Drug: Celecoxib; Drug: Rosuvastatin; Drug: Midazolam; Drug: Dabigatran etexilate; Drug: BGB-43395

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 877-828-5568; Email: clinicaltrials@beonemed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Participants will receive midazolam and celecoxib alone and with BGB-43395.	Drug: Celecoxib; Administered orally; Drug: Midazolam; Administered orally; Drug: BGB-43395; Administered orally
Experimental: Part 2; Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.	Drug: Rosuvastatin; Administered orally; Drug: Dabigatran etexilate; Administered orally; Drug: BGB-43395; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first dose up to 17 days

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Collaborators: Fortrea
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Estimated): September 24, 2026
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): November 22, 2026

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Pyrimidines; Benzene Derivatives; Hydrocarbons, Halogenated; Benzazepines; Benzenesulfonamides; Sulfonamides; Sulfones; Benzodiazepines; Pyrazoles; Fluorobenzenes; Hydrocarbons, Fluorinated; Celecoxib; Dabigatran; Rosuvastatin Calcium; Midazolam
• Other Study ID Numbers: BGB-43395-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No