A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants

September 3, 2025 updated by: BeiGene

A Phase 1, Open-label, Randomized, Crossover Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-43395 in Healthy Participants

Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117-5116
        • Fortrea Cru, Daytone Beach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female, of any race, between 18 and 65 years of age
  • 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
  • Able to comprehend and are willing to sign the ICF and abide by the study restrictions

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 or designee
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
  • Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute. If any parameter is out of range, measurements should be repeated twice. Participants will be excluded if the average of the 3 measurements are outside of the corresponding reference range.
  • History of prolonged QT interval/QT interval corrected for heart rate, with QTcF >450 ms for males and >470 ms for females.
  • History or current diagnosis of diabetes, with a HbA1c ≥6.5% or fasting blood glucose level ≥126 mg/dL at screening alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5 × upper limit of normal (ULN) (except for participants with Gilbert's syndrome, where total bilirubin should not be >2 × ULN) at screening and check-in.
  • eGFR <90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021)
  • Hemoglobin <lower limit of normal (LLN), white blood cell count <LLN, absolute neutrophil count <LLN, or platelet count <LLN at screening and check-in.
  • Positive hepatitis panel and/or positive human immunodeficiency virus test.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Relative Bioavailability
Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences.
Drug: BGB-43395
Administered orally as solid dispersion tablet or salt tablet
Experimental: Part 2: Food Effect
Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences.
Drug: BGB-43395
Administered orally as solid dispersion tablet or salt tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Maximum Observed Concentration (Cmax)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Time of the Maximum Observed Concentration (Tmax)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Terminal Elimination Half-life (t1/2)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Total Clearance (CL/F)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Part 1 and 2: Apparent Volume of Distribution (Vz/F)
Time Frame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Approx 38 days in Part 1 and 45 days in part 2
Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant laboratory values
Time Frame: Approx 38 days in Part 1 and 45 days in part 2
Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant electrocardiogram (ECG) results
Time Frame: Approx 38 days in Part 1 and 45 days in part 2
Approx 38 days in Part 1 and 45 days in part 2
Number of participants with clinically significant vital sign measurements
Time Frame: Approx 38 days in Part 1 and 45 days in part 2
Approx 38 days in Part 1 and 45 days in part 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director Study Director, BeiGene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-43395-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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