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

Launched by BEIGENE · Dec 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BGB-43395 to see how well different forms of the drug are absorbed by the body and how food affects its absorption. The trial involves healthy adult volunteers and is divided into two parts. In the first part, researchers will compare how well a solid dispersion tablet of BGB-43395 works compared to a salt tablet. In the second part, they will look at how eating food impacts the effectiveness of these tablets.

To participate, volunteers need to be between 18 and 65 years old and generally in good health. They should not have any serious medical conditions or allergies that could affect the study. Participants will be closely monitored throughout the trial to ensure their safety. It's important for anyone considering joining the trial to fully understand the study requirements and be willing to follow the rules set by the researchers. This trial is currently recruiting participants, so if you or someone you know is interested, it could be a great opportunity to contribute to medical research!

Gender

ALL

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.