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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tablet called BGB-43395 in healthy adults. Researchers aim to compare how the body absorbs this tablet to a different version and assess the impact of food on its absorption. Individuals in good health without significant medical issues may qualify for participation. Participants will receive different doses under varied conditions, such as fasting or after eating. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that BGB-43395 is likely to be safe for humans?

Previous research has found BGB-43395 to be generally safe and tolerable. One study showed that most patients experienced mild side effects, such as minor headaches or slight nausea. These findings suggest that BGB-43395 is well-tolerated, supporting further testing and development. Although still in the early stages, this data is promising for its safety profile in healthy participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BGB-43395 is unique because it aims to optimize the body's absorption of the drug by exploring different formulations and how food intake affects its absorption. Unlike typical treatments that have a fixed method of delivery, BGB-43395 could offer flexibility and improved effectiveness by considering how food influences its processing in the body. Researchers are excited about its potential to enhance bioavailability, which might lead to better outcomes and fewer side effects compared to standard treatments.

What evidence suggests that this trial's treatments could be effective?

BGB-43395 is still under investigation, so limited information exists on its efficacy. Research primarily examines the drug's absorption and behavior in the body. In this trial, participants will receive BGB-43395 in different formulations and under various conditions to study its bioavailability and the effect of food on its absorption. Scientists continue to explore its potential benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

Study Director Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06761898

A Study of Different Forms of BGB-43395 and Food Effect ... Study Overview. Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06253195

Study Details | NCT06253195 | BGB-43395 Alone or as ... This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary ...

3. trialx.com trialx.com/5-recruiting-breakthrough-clinical-trials-exploring-new-approaches-to-ovarian-cancer-care/

5 Recruiting Breakthrough Clinical Trials Exploring New ... Researchers are looking at how the drug works on its own and in combination with other treatments like fulvestrant, and sometimes BGB-43395.

4. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?id=23633&isClinicalTrial=True

ANZCTR - Registration Experimental: Part 1B: BGB-21447 + BGB-43395 ... Experimental: BGB-21447 + Fulvestrant Food Effect Substudy - Participants will receive BGB ...

5. synapse.patsnap.com synapse.patsnap.com/drug/af552af0fd77484e94c9b8f253f6c020

BGB-43395 - Drug Targets, Indications, Patents Of the 37 efficacy-evaluable patients (all with monotherapy), unconfirmed overall response rate (ORR) was 5.4% (2/37; 95% CI: 0.7%–18.2%). Two extensively ...

6. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/P4-10-20/752580/Abstract-P4-10-20-First-in-human-phase-1a-dose

First-in-human phase 1a, dose-escalation study of BGB-43395 ... To date, BGB-43395 has been safe and tolerable, supporting continued development. The dose-escalation phase is currently ongoing. Citation ...

7. beonemedinfo.com beonemedinfo.com/CongressDocuments/Yap_BGB-43395-101_SABCS_Poster_2024.pdf

First-in-human phase 1a, dose-escalation study of BGB- ... Safety. • TEAEs occurred in 61/65 (93.8%) patients overall, and were primarily grades (gr) 1 and 2 (Table 2). • For all 65 patients, ...

8. duke-research.dukehealth.org duke-research.dukehealth.org/studies/pro00114226

BeiGene BGB-43395-101 (Advanced Solid Tumors) We are doing this study to find out if an experimental drug called BGB-43395 (the study drug) is a safe and effective option for people with for breast cancer ...