INCB000631 for Healthy Adults

Overseen ByIncyte Corporation Call Center (ex-US)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: CYP3A4 inhibitors, others

Disqualifiers: Cardiovascular disease, Hypertension, Autoimmune, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a new treatment, INCB000631 (an experimental treatment), works in healthy adults. The main goals are to assess its safety, how the body processes it, and whether food affects its effectiveness. Participants will receive either the treatment or a placebo (a harmless pill used for comparison) across several groups. It suits those who are healthy, have no major ongoing health issues, and can swallow tablets. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that INCB000631 is likely to be safe for humans?

Research shows that INCB000631 is in early testing stages, focusing on safety in humans. This Phase 1 trial marks the first time the treatment is tested in people. Currently, there is no clear information on tolerance or side effects. This phase typically involves small groups of healthy volunteers to closely monitor their body's response. The safety information collected in this trial is essential for understanding how safe INCB000631 is for human use.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

INCB000631 is unique because it introduces a new approach to treatment by targeting specific pathways that current medications don't. While most treatments for similar conditions work by addressing symptoms broadly, INCB000631 is designed to act more precisely at the molecular level, potentially offering more effective relief with fewer side effects. Researchers are excited about this treatment because it could lead to a more targeted and personalized approach to care, ultimately improving patient outcomes.

What evidence suggests that INCB000631 could be effective?

Research has shown that INCB000631 is under study primarily to assess its safety and mechanism of action in the body. Limited information exists on its effectiveness in treating specific conditions. This trial aims to understand its safety, tolerability, and pharmacokinetics. Participants will be assigned to different treatment arms, with some receiving INCB000631 and others a placebo. No specific results have yet demonstrated its effectiveness for any particular health issue. The main goal is to ensure its safety and understand its effects on healthy adults.¹ ² ³ ⁶ ⁷

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 adults aged 19 to 55 with a BMI between 18.0 and 32.0, who can understand and sign consent forms, swallow tablets, and agree to prevent pregnancy or fathering children during the study. Those with significant health issues on screening tests cannot participate.

Inclusion Criteria

Ability to comprehend and willingness to sign a written ICF for the study

Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled with a body mass index > 30 to ≤ 32.0 kg/m2

No clinically significant findings on screening evaluations (clinical, laboratory [except lipids], and ECG) as determined by the investigator. If the investigator has questions about clinically significant findings, the medical monitor should be consulted

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Exclusion Criteria

I have not had major surgery in the last 4 weeks.

History of an autoimmune disease (eg, myasthenia gravis)

I have a condition like Crohn's disease that affects how my body absorbs drugs.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of INCB000631 or placebo to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect

Up to 14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events

Up to 41 days

What Are the Treatments Tested in This Trial?

Interventions

INCB000631

Trial Overview The trial is testing INCB000631, an oral medication, against a placebo in terms of safety, how well it's tolerated by the body, its behavior inside the body (pharmacokinetics), its effects on the body (pharmacodynamics), and how food affects it.

How Is the Trial Designed?

8Treatment groups

Experimental Treatment

Group I: Optional Cohort FExperimental Treatment2 Interventions