Testing different forms of BGB-43395 and how food affects it in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the relative bioavailability of two formulations of BGB-43395, a solid dispersion tablet and a salt tablet, in healthy adult participants. It consists of two parts: the first part compares the absorption of the two tablet forms, while the second part assesses how food intake influences the pharmacokinetics of the selected formulation. The study will involve healthy volunteers aged 18 to 65, who will be monitored for their health status and adherence to study protocols.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fortrea Cru, Daytone Beach
  Daytona Beach, Florida, United States Recruiting

Study contacts

• Study coordinator: Study Director Study Director
• Email: clinicaltrials@beigene.com
• Phone: 1-877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.