INCB000631 for Healthy Adults

Overseen ByIncyte Corporation Call Center (ex-US)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Incyte Corporation

Must not be taking: CYP3A4 inhibitors, others

Disqualifiers: Cardiovascular disease, Hypertension, Autoimmune, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants.

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.

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

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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Trial Timeline

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

Treatment Details

Interventions

INCB000631 (Other)

Trial OverviewThe 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.

Participant Groups

8Treatment groups

Experimental Treatment

Group I: Optional Cohort FExperimental Treatment2 Interventions