COMPLETED

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

Conditions

Healthy Volunteers BGB-43395 Relative Bioavailability Effect of Food Pharmacokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-14

Study Completion:2025-05-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06761898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Study Director Study Director

STUDY_DIRECTOR

BeiGene

Study Locations (Sites)

Fortrea Cru, Daytone Beach

Daytona Beach, Florida, 32117-5116

United States

Collaborators and Investigators

Sponsor: BeiGene

Study Director Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-14

Study Completion Date2025-05-20

Study Record Updates

Study Start Date2025-01-14

Study Completion Date2025-05-20

Terms related to this study

Keywords Provided by Researchers

BGB-43395
Relative Bioavailability
Effect of Food
Pharmacokinetics

Additional Relevant MeSH Terms

Healthy Volunteers