Healthy Volunteers
Conditions
Keywords
BGB-43395, Relative Bioavailability, Effect of Food, Pharmacokinetics
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.
Interventions
DRUGBGB-43395
Administered orally as solid dispersion tablet or salt tablet
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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: 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of Participants with Adverse Events (AEs) | Approx 38 days in Part 1 and 45 days in part 2 |
Countries
United States
Outcome results
None listed