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Completed

NCT Number: NCT06761898

A Study of Different Forms of BGB-43395 and Food Effect 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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Cru, Daytone Beach

Daytona Beach, Florida, 32117-5116, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BGB-43395

Drug

Administered orally as solid dispersion tablet or salt tablet

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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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