A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants
Phase 1
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Drug: BGB-43395
- Registration Number
- NCT06761898
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 48
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: Relative Bioavailability BGB-43395 Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences. Part 2: Food Effect BGB-43395 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.
- Primary Outcome Measures
Name Time Method 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: 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: 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 Outcome Measures
Name Time Method 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