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

NCT06761898 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-43395-103
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

BGB-43395; Relative Bioavailability; Effect of Food; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)

  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)

  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)

  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)

  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)

  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)

  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)

  PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2

Secondary Outcomes (4)

• Number of Participants with Adverse Events (AEs)

  Approx 38 days in Part 1 and 45 days in part 2

• Number of participants with clinically significant laboratory values

  Approx 38 days in Part 1 and 45 days in part 2

• Number of participants with clinically significant electrocardiogram (ECG) results

  Approx 38 days in Part 1 and 45 days in part 2

• Number of participants with clinically significant vital sign measurements

  Approx 38 days in Part 1 and 45 days in part 2

Study Arms (2)

Part 1: Relative Bioavailability

EXPERIMENTAL

Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences.

Drug: BGB-43395

Part 2: Food Effect

EXPERIMENTAL

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

BGB-43395 DRUG

Administered orally as solid dispersion tablet or salt tablet

Part 1: Relative Bioavailability

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Fortrea Cru, Daytone Beach

Daytona Beach, Florida, 32117-5116, United States

Location

Study Officials

• Study Director Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: January 14, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)