Povorcitinib for Healthy Subjects

Overseen By Incyte Corporation Call Center (US)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Incyte Corporation

Must not be taking: CYP3A4 drugs

Disqualifiers: Cardiovascular disease, Hypertension, Malabsorption, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

71 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to Assess the Effect of Povorcitinib on Digoxin, Rosuvastatin, and Metformin Pharmacokinetics and the Effect of Probenecid on Povorcitinib Pharmacokinetics When Administered Orally to Healthy Adult Participants.

Research Team

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Eligibility Criteria

This clinical trial is for healthy adults. Specific eligibility criteria are not provided, but typically participants should have no significant health issues and be on no other medications that could affect the study results.

Inclusion Criteria

No clinically significant findings on screening evaluations (eg, clinical, laboratory, and ECG evaluations)

Willingness to avoid pregnancy or fathering children based on specific criteria for male and female participants

I can swallow and keep down pills.

Exclusion Criteria

I cannot have blood drawn from my veins.

I do not have any active infections.

History or presence of an abnormal ECG

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive oral administration of povorcitinib with digoxin, rosuvastatin, metformin, or probenecid as per cohort assignment

3 weeks

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Povorcitinib

Trial Overview The study is testing how Povorcitinib affects the body's handling of three drugs: Digoxin (used for heart problems), Rosuvastatin (for cholesterol), and Metformin (for diabetes) when taken by mouth in healthy people.

Participant Groups

Group I: Cohort 4: Dose Experimental Treatment 2 Interventions

Probenecid and povorcitinib will be administered at protocol defined doses.

Group II: Cohort 3: Dose Experimental Treatment 2 Interventions

Metformin and povorcitinib will be administered at protocol defined doses.

Group III: Cohort 2: Dose Experimental Treatment 2 Interventions

Rosuvastatin and povorcitinib will be administered at protocol defined doses.

Group IV: Cohort 1: Dose Experimental Treatment 2 Interventions

Digoxin and povorcitinib will be administered at protocol defined doses.

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