Clinical trial NCT06761898: A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BGB-43395
Relative Bioavailability
Effect of Food
Pharmacokinetics
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part 1 and 2: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
measure: Part 1 and 2: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
measure: Part 1 and 2: Maximum Observed Concentration (Cmax)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
measure: Part 1 and 2: Time of the Maximum Observed Concentration (Tmax)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
measure: Part 1 and 2: Apparent Terminal Elimination Half-life (t1/2)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
measure: Part 1 and 2: Apparent Total Clearance (CL/F)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
measure: Part 1 and 2: Apparent Volume of Distribution (Vz/F)
timeFrame: PK is assessed on days 1-15 in Part 1 and Days 1- 22 for part 2
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Approx 38 days in Part 1 and 45 days in part 2
measure: Number of participants with clinically significant laboratory values
timeFrame: Approx 38 days in Part 1 and 45 days in part 2
measure: Number of participants with clinically significant electrocardiogram (ECG) results
timeFrame: Approx 38 days in Part 1 and 45 days in part 2
measure: Number of participants with clinically significant vital sign measurements
timeFrame: Approx 38 days in Part 1 and 45 days in part 2
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Cru, Daytone Beach
state: Florida
Study officials:
affiliation: BeiGene
name: Study Director Study Director
role: STUDY_DIRECTOR
References: