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

48 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

The purpose of this study is to evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants.

Research Team

Incyte Study Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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