INCB123667 for Healthy Subjects

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: CYP3A4 inducers, CYP3A4 inhibitors

Disqualifiers: Cardiovascular disease, GI disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Single dose administration

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the new drug, INCB123667, behaves in the body. Researchers examine its absorption, distribution, metabolism, and excretion by administering a single oral dose with a special marker to healthy male participants. Eligible participants should be generally healthy men who can swallow pills and meet specific health criteria, such as not having significant health conditions like heart or stomach issues.

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 taking my current medications for the trial?

The trial requires that you stop taking any medications known to affect certain enzymes (CYP3A4, BCRP, or P-gp) at least 15 days before the study. If you're on such medications, you may need to stop them before participating.

Is there any evidence suggesting that INCB123667 is likely to be safe for humans?

Research has shown that INCB123667 has promising safety results from early studies. Patients with certain types of cancer generally tolerated this treatment well, and it had a manageable safety profile. Some patients had advanced cancer with specific genetic traits, making the findings encouraging.

These studies reported some side effects, but they were mostly mild and manageable. This suggests the treatment could be safe for use in humans. However, the trial remains in its early stages, focusing primarily on ensuring the treatment's safety for healthy volunteers. While initial results are positive, researchers continue to study the safety of INCB123667. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

INCB123667 is unique because it introduces a new approach by using a radiolabeled form of the drug. Unlike traditional treatments that might rely on different mechanisms, this approach allows researchers to track how the drug moves and is processed in the body, offering insights that could lead to more targeted therapies. Researchers are excited about this treatment's potential to provide a deeper understanding of drug absorption and metabolism, which could pave the way for developing more effective treatments in the future.

What evidence suggests that INCB123667 could be effective?

Research has shown that INCB123667 is a promising treatment because it targets CDK2, a protein that aids cell division and growth. This is crucial because some cancer cells rely on this protein to multiply. Early studies found that INCB123667 can effectively halt the growth of these cancer cells, potentially preventing cancer from spreading. Although research on INCB123667 remains in the early stages, its ability to specifically target CDK2 without affecting other similar proteins is promising. Participants in this trial will receive INCB123667 to further evaluate its effects. ^{2 6 7 8 9}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for healthy men aged 18 to 55 with a BMI of 18.0-32.0 kg/m2 who can understand and sign the consent form, have no significant health issues based on screening tests, and are able to swallow oral medication.

Inclusion Criteria

I am a healthy male between 18 and 55 years old.

My BMI is between 18.0 and 32.0.

My screening tests show no significant health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of INCB123667 followed by an oral dose solution of radiolabeled INCB123667

Single dose administration

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics and metabolite profiles, including total recovery of radioactivity and treatment emergent adverse events

Up to approximately 2 months

What Are the Treatments Tested in This Trial?

Interventions

• INCB123667

Trial Overview The study is testing INCB123667 by giving a single oral dose with radioactive labeling ([14C]) to track how the drug is processed in the body, including its breakdown and elimination.

How Is the Trial Designed?

Group I: Treatment: INCB123667 Experimental Treatment 1 Intervention

Participants will be administered INCB123667 tablet orally, followed approximately 10 minutes later by an oral dose solution of radiolabeled INCB123667.

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. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incytes-cdk2-inhibitor-incb123667-shows-promising-evidence/

Incyte's CDK2 Inhibitor INCB123667 Shows Promising ... This open-label, dose-escalation and dose-expansion Phase 1 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and ...

2. incytemi.com incytemi.com/document/Poster/ESMO%202024%20-%20INCB123667%20CDK2%20Phase%201%20Study%20(presentation).pdf

Safety and Tolerability of INCB123667, a Selective CDK2 ... CDK2/cyclin E is crucial for cell cycle progression and DNA replication. • Cancer cells with CCNE1 amplification/cyclin E1 overexpression are dependent on ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05238922

NCT05238922 | Study of INCB123667 in Subjects With ... This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12434667/

Discovery of Selective and Orally Bioavailable ... Based on its potency, selectivity over CDK1, and in vivo pharmacokinetic (PK) properties in rats, 37 was characterized further. The selectivity ...

5. trial.medpath.com trial.medpath.com/clinical-trial/62780cd17653d8b7/nct06909162-food-effect-pharmacokinetics-incb123667

A Study to Evaluate the Effect of Food on the Single-Dose ... This study will be conducted to evaluate the effect of food on the single-dose pharmacokinetics of INCB123667 when administered orally to healthy adult ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05238922

NCT05238922 | Study of INCB123667 in Subjects With ... This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02203-8/pdf

617MO Safety and tolerability of INCB123667, a selective ... Conclusions: INCB123667 was generally well tolerated with promising antitumor activity in pts with cyclin E1 overexpressing or CCNE1 amplified advanced/ ...

8. incytemi.com incytemi.com/document/Poster/ASCO%202025%20-%20INCB123667%20(CDK2%20inhibitor)%20in%20Ovarian%20Cancer%20(oral%20presentation).pdf

ASCO 2025 - INCB123667 (CDK2 inhibitor) in Ovarian ... ○ INCB123667 showed manageable safety ... ○ A manageable safety profile was observed in patients with ovarian cancer at the doses selected for ...

9. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2025-2bc8f

INCB123667 for Healthy Subjects Healthy adults aged 19 to 55, with a BMI of 18.0-32.0 kg/m2 can join this trial. They must be able to swallow tablets, have no significant ...