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CompletedNCT06761898Updated Sep 4, 2025

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

A Phase 1 interventional study of BGB-43395 and BGB-43395 in Healthy Volunteers, sponsored by BeiGene. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by BeiGene · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • BGB-43395
  • Relative Bioavailability
  • Effect of Food
  • Pharmacokinetics
03

In context

Lead sponsor

BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugBGB-43395

    Administered orally as solid dispersion tablet or salt tablet

  • DrugBGB-43395

    Administered orally as solid dispersion tablet or salt tablet

06

What researchers measure

Primary outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Approx 38 days in Part 1 and 45 days in part 2

  2. Number of participants with clinically significant laboratory values

    Time frame: Approx 38 days in Part 1 and 45 days in part 2

  3. Number of participants with clinically significant electrocardiogram (ECG) results

    Time frame: Approx 38 days in Part 1 and 45 days in part 2

  4. Number of participants with clinically significant vital sign measurements

    Time frame: Approx 38 days in Part 1 and 45 days in part 2

07

Study locations

1 site
  • Fortrea Cru, Daytone Beach
    Daytona Beach, Florida 32117-5116, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06761898
Lead sponsor
BeiGene
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
Jan 14, 2025
Primary completion
May 20, 2025
Completion
May 20, 2025
Last update
Sep 4, 2025

Study contacts

Study Director Study Director
study director · BeiGene

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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