INCB057643 for Healthy Subjects

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: Prescription drugs

Disqualifiers: Cardiovascular, Hypertension, GI disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different versions of a tablet called INCB057643 to assess their absorption when taken orally. The goal is to understand how the body processes these new tablet formulations in healthy individuals. The trial divides participants into multiple groups, each receiving a different dose to identify the most effective one. Healthy individuals aged 18 to 55 who can take oral medications might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I need to stop taking my current medications for this trial?

Yes, you will need to stop taking prescription drugs within 14 days and nonprescription medications within 7 days before the study drug is given, except for occasional standard-dose acetaminophen, ibuprofen, and standard-dose vitamins.

Is there any evidence suggesting that INCB057643 is likely to be safe for humans?

Research has shown that INCB057643 is generally well-tolerated. Previous studies found that this treatment does not cause life-threatening side effects related to the medication. Participants in these studies responded well to the treatment, whether taken alone or with another drug called ruxolitinib.

One study noted that most people found this medication easy to handle, experiencing no serious side effects. While individual reactions can vary, overall evidence from past studies suggests that INCB057643 is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

INCB057643 is unique because it targets the BET proteins, which are linked to gene regulation in various diseases, offering a new mechanism of action compared to traditional therapies. While many standard treatments focus on alleviating symptoms or slowing disease progression through different pathways, INCB057643 directly interrupts the disease-related pathways at the genetic level. Researchers are excited about this treatment's potential to offer a more precise and targeted approach, potentially leading to more effective and quicker outcomes.

What evidence suggests that INCB057643 could be effective?

Studies have shown that INCB057643, a drug that blocks certain proteins involved in cancer growth, is generally well tolerated and shows promise in treating some blood disorders. Research on patients with advanced myelofibrosis, a type of bone marrow cancer, demonstrated improvements in spleen size, symptoms, and anemia. Previous patients tolerated the drug well and showed positive clinical results. No treatment-related deaths occurred in these studies, highlighting its safety. While the data mainly focuses on blood disorders, the drug's mechanism suggests potential benefits for other conditions. In this trial, researchers will administer different doses of INCB057643 to healthy subjects to further evaluate its safety and tolerability. ^{1 2 4 6 7}

Who Is on the Research Team?

Incyte Study Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 55 with a BMI between 18.0 and 32.0 kg/m2 who can understand and sign the consent form. Participants must have no significant health issues on clinical, lab, or ECG tests and be able to swallow oral medication.

Inclusion Criteria

I can understand and am willing to sign the consent form for the study.

My BMI is between 18.0 and 32.0.

I can swallow and keep down pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive INCB057643 at protocol-defined doses to evaluate relative bioavailability

Up to 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 16 days

What Are the Treatments Tested in This Trial?

Interventions

• INCB057643

Trial Overview The study is testing the relative bioavailability of new oral tablet formulations of INCB057643 in healthy participants to see how well the drug is absorbed by their bodies.

How Is the Trial Designed?

Group I: Cohort 4: Dose Treatment E Experimental Treatment 1 Intervention

INCB057643 will be administered at protocol defined dose.

Group II: Cohort 4: Dose Treatment D Experimental Treatment 1 Intervention

INCB057643 will be administered at protocol defined dose.

Group III: Cohort 3: Dose Treatment C Experimental Treatment 1 Intervention

INCB057643 will be administered at protocol defined dose.

Group IV: Cohort 2: Dose Treatment B Experimental Treatment 1 Intervention

INCB057643 will be administered at protocol defined dose.

Group V: Cohort 1: Dose Treatment A Experimental Treatment 1 Intervention

INCB057643 will be administered at protocol defined dose.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/658/530241/Safety-and-Efficacy-of-Bromodomain-and-Extra

Safety and Efficacy of Bromodomain and Extra-Terminal ... Conclusions: Treatment with INCB057643 monotherapy or in combo with RUX was generally well tolerated, with no treatment-related fatal events.

2. bloodcancerstoday.com bloodcancerstoday.com/post/bet-inhibitor-incb057643-demonstrates-activity-in-relapsed-or-refractory-myelofibrosis-and-other-myeloid-neoplasms

BET Inhibitor INCB057643 Demonstrates Activity in ... INCB057643 was generally well tolerated and demonstrated activity across endpoints, with improvements in spleen size, symptom burden, and anemia ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6574

Safety and efficacy of bromodomain and extra-terminal ... The oral, small-molecule BET inhibitor INCB057643 had favorable tolerability and encouraging clinical activity in pts with advanced MF in a previous Ph 1/2 ...

4. incytemi.com incytemi.com/document/Poster/EHA%202025%20-%20INCB057643%20(BET%20inhibitor)%20Safety%20and%20Efficacy%20in%20MF%20(poster).pdf

EHA 2025 - INCB057643 (BET inhibitor) Safety and ... 4 patients were not evaluable: 2 had baseline TSS of 0 (6 mg and 8 mg, n=1 each) and 2 did not have baseline data (4 mg and 10 mg, n=1 each).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04279847

Study Details | NCT04279847 | Safety and Tolerability ... The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for ...

6. mpn-hub.com mpn-hub.com/medical-information/limber-safety-and-tolerability-of-incb057643-in-patients-with-mf-and-other-advanced-mpn

LIMBER: Safety and tolerability of INCB057643 in patients ... Here, we present a visual abstract outlining the trial design and summarizing key efficacy and safety data to date from the phase I LIMBER ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02711137

NCT02711137 | Open-Label Safety and Tolerability Study ... The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination ...