Recruiting
Phase 1

BGB-43395 with Midazolam, Celecoxib, Dabigatran, Rosuvastatin

Sponsor:

BeOne Medicines

Code:

NCT07820891

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

BGB-43395

Midazolam

Celecoxib

Dabigatran etexilate

Rosuvastatin

Study Details

Brief summary:

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

Conditions

Healthy Adult Participants

Study ID

NCT07820891

Start date

Sep 25, 2026

Status verified date

Oct, 2026

Completion date

Nov 22, 2026

Anticipated

Primary completion date

Nov 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1

Participants will receive midazolam and celecoxib alone and with BGB-43395.

experimental: Part 2

Participants will receive dabigatran and rosuvastatin alone and with BGB-43395.

Interventions

BGB-43395

Administered orally

Midazolam

Administered orally

Celecoxib

Administered orally

Dabigatran etexilate

Administered orally

Rosuvastatin

Administered orally

Primary outcome measure

  • Area Under the Concentration Time Curve from Time Zero to Infinity (AUC0-inf) [ 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) [ Time Frame: Samples will be collected predose and at specified timepoints, up to 10 days ]
  • Maximum Observed Concentration (Cmax) [ Time Frame: Samples will be collected predose and at specified timepoints, up to 10 days ]
  • Time to Reach Maximum Observed Concentration (Tmax) [ Time Frame: Samples will be collected predose and at specified timepoints, up to 10 days ]

Central Contacts and Locations

Central contacts

Study Director

877-828-5568clinicaltrials@beonemed.com

Locations

Fortrea CRU

Recruiting

Dallas, Texas, United States, 75247

More Information

Sponsor

BeOne Medicines

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.