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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

BeiGene

Investigators

  • 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)

January 14, 2025

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Healthy Volunteers

Clinical Trials on BGB-43395

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe