Health TrialsbyHealthPanel

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

ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeOne Medicines

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index between 18.0 and 32.0 kg/m², 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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BGB-43395

    Drug

    Administered orally

  • Midazolam

    Drug

    Administered orally

  • Celecoxib

    Drug

    Administered orally

  • Dabigatran etexilate

    Drug

    Administered orally

  • Rosuvastatin

    Drug

    Administered orally

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Part 1Experimental treatment 3 interventions
Group B: Part 2Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

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.

Time frame
From first dose up to 17 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BeOne Medicines

Lead sponsor

Fortrea

Collaborator

Source ClinicalTrials.gov
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