Testing different forms of BGB-43395 and how food affects it in healthy adults
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
This study tests how well two different types of a new medication, BGB-43395, are absorbed in healthy adults and how food affects this absorption.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | BeiGene Industry-sponsored |
| Locations | 1 site (Daytona Beach, Florida) |
| Trial ID | NCT06761898 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male and female adults aged 18 to 65 with a body mass index between 18.0 and 32.0 kg/m2.
Not a fit: Patients with significant medical histories or conditions that could affect drug absorption or metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the optimal formulation and administration of BGB-43395, potentially improving its effectiveness for future therapeutic use.
How similar studies have performed: While this study focuses on a specific formulation of BGB-43395, similar pharmacokinetic studies have shown success in optimizing drug delivery methods.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Daytona Beach, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.