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Healthy volunteers help Fine-Tune new Drug's absorption
NCT ID NCT06761898
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 1 study looked at how two different tablet forms of the drug BGB-43395 are absorbed in 51 healthy adults aged 18-65. It also checked whether taking the drug with food changes absorption. The goal was to gather basic information, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BGB-43395
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
51 people
The number who actually took part.
- Started
-
Jan 2025
- Finished
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May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fortrea Cru, Daytone Beach
Daytona Beach, Florida, 32117-5116, United States
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