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BGB-43395 for Healthy Subjects
Daytona Beach, FL
Phase 1
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, of any race, between 18 and 65 years of age
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare how well a new tablet (BGB-43395) works compared to a different type of tablet in healthy adults. In Part 1, they will look at how the new
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Who is the study for?
This trial is for healthy adults aged 18-65 with a BMI between 18.0 and 32.0 kg/m2. Participants must be in good health without significant medical history findings and willing to follow study rules.Check my eligibility
What is being tested?
The study tests two forms of BGB-43395 (solid dispersion tablet vs salt tablet) for absorption in the body, and how food affects its absorption.See study design
What are the potential side effects?
Since this is a trial involving healthy participants, specific side effects are not listed but may include typical drug-related reactions such as nausea, headache, or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes with high blood sugar or liver enzyme levels.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Food EffectExperimental Treatment1 Intervention
Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences.
Group II: Part 1: Relative BioavailabilityExperimental Treatment1 Intervention
Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences.
Find a Location
Closest Location:Fortrea Cru, Daytone Beach· Daytona Beach, FL
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BeiGeneLead Sponsor
215 Previous Clinical Trials
32,360 Total Patients Enrolled
Study Director Study DirectorStudy DirectorBeiGene
6 Previous Clinical Trials
1,735 Total Patients Enrolled