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

NCT ID: NCT06761898

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2025-05-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: Relative Bioavailability

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

Group Type: EXPERIMENTAL

BGB-43395

Intervention Type: DRUG

Administered orally as solid dispersion tablet or salt tablet

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.

Group Type: EXPERIMENTAL

BGB-43395

Intervention Type: DRUG

Administered orally as solid dispersion tablet or salt tablet

Interventions

BGB-43395

Administered orally as solid dispersion tablet or salt tablet

Intervention Type: DRUG

BGB-43395

Administered orally as solid dispersion tablet or salt tablet

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

Fortrea Cru, Daytone Beach

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

BGB-43395-103

Identifier Type: -

Identifier Source: org_study_id