BGB-43395 for Healthy Subjects

Overseen By Study Director Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Diabetes, Hypertension, QT prolongation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

48 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's possible that taking medications could affect eligibility. Please consult with the trial organizers for more details.

What is the purpose of this trial?

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.

Research Team

Study Director Study Director

Principal Investigator

BeiGene

Eligibility Criteria

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.

Inclusion Criteria

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

History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single dose of each formulation of BGB-43395 in separate periods to determine relative bioavailability

4 weeks

Multiple visits (in-person)

Treatment Part 2

Participants receive three doses of the selected formulation of BGB-43395 under different dietary conditions to assess food effect

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BGB-43395

Trial Overview 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.

Participant Groups

Group I: Part 2: Food Effect Experimental Treatment 1 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 Bioavailability Experimental Treatment 1 Intervention

Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+