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Clinical Trials in the USA / NCT07820891
Recruiting Phase 1

A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395

NCT07820891 · tracked via the Priya Life Science USA tracker
Sponsor
BeOne Medicines
Phase
Phase 1
Started
2026-09-25
Last updated
2026-10-08

Condition(s) studied

Healthy Adult Participants

Investigational drug(s) / intervention(s)

BGB-43395 →Midazolam →Celecoxib →Dabigatran etexilate →Rosuvastatin →

BGB-43395: Administered orally

Midazolam: Administered orally

Celecoxib: Administered orally

Dabigatran etexilate: Administered orally

Rosuvastatin: Administered orally

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf) — Samples will be collected predose and at specified timepoints, up to 10 days
    AUC0-inf for midazolam, celecoxib, dabigatran, and rosuvastatin.
  • Area Under the Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-tlast) — Samples will be collected predose and at specified timepoints, up to 10 days
    AUC0-tlast for midazolam, celecoxib, dabigatran, and rosuvastatin.
  • Maximum Observed Concentration (Cmax) — Samples will be collected predose and at specified timepoints, up to 10 days
    Cmax for midazolam, celecoxib, dabigatran, and rosuvastatin.
  • Time to Reach Maximum Observed Concentration (Tmax) — Samples will be collected predose and at specified timepoints, up to 10 days
    Tmax for midazolam, celecoxib, dabigatran, and rosuvastatin.

Trial sites (1)

FacilityCityRegionStatus
Fortrea CRU Dallas Texas Recruiting

On this site

📄 Crestor (rosuvastatin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07820891 on ClinicalTrials.gov ↗ ← All trials in the USA