INCB000631 for Healthy Adults

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Incyte Corporation

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.

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

I am between 19 and 55 years old.

I can swallow and keep down pills.

Exclusion Criteria

I have not received a live vaccine within the last 3 months.

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

I haven't had major gut surgery or disease in the last 3 months.

I am not on long-term antibiotics or antivirals for an ongoing infection.

I am not taking any medications that are not allowed in the study.

I have a history of heart, brain, blood vessel, or clotting problems, or my high blood pressure is not under control.

My resting heart rate is either below 40 or above 100 bpm.

I have not had more than the recommended amount of alcohol in the last 3 months.

My heart's electrical activity is normal as per my last ECG.

Participant Groups

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.

8Treatment groups

Experimental Treatment

Group I: Optional Cohort FExperimental Treatment2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose.

Group II: Cohort G Treatment BExperimental Treatment1 Intervention

INCB000631 will be administered at the protocol defined dose.

Group III: Cohort G Treatment AExperimental Treatment1 Intervention

INCB000631 will be administered at the protocol defined dose.

Group IV: Cohort EExperimental Treatment2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose.

Group V: Cohort DExperimental Treatment2 Interventions

INCB000631 or placebo will be administered at the protocol defined dose.