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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the new drug Povorcitinib interacts with common medications like Digoxin, Rosuvastatin, Metformin, and Probenecid. The researchers aim to determine if Povorcitinib alters how these drugs function or are metabolized. Healthy adults without significant health issues who can take oral medication are ideal candidates for this study. Participants will contribute to understanding drug interactions, which could be crucial for future treatments. As a Phase 1 trial, this research focuses on understanding Povorcitinib's effects in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking prescription drugs 14 days before the study and nonprescription medications 7 days before the study, except for occasional paracetamol, ibuprofen, and standard-dose multivitamins.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that povorcitinib is generally safe for use. Earlier studies found no increase in side effects with varying doses of the drug. In one study, when patients switched from a placebo to povorcitinib, the rate of treatment-emergent adverse events (TEAEs) ranged from 42.4% to 70.2%. This indicates that while some experienced side effects, many did not, and the drug was generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Povorcitinib is unique because it combines with existing medications like rosuvastatin, metformin, digoxin, and probenecid to potentially enhance their effects. Unlike current treatments that typically focus on a single mechanism, povorcitinib may offer a synergistic approach, potentially improving efficacy and safety profiles. Researchers are excited about its novel approach to modulating immune response, which could make it a versatile option across various conditions.

What evidence suggests that this trial's treatments could be effective?

Research has shown that povorcitinib effectively treats hidradenitis suppurativa (HS), a skin condition causing painful lumps under the skin. In earlier studies, patients taking povorcitinib experienced a noticeable reduction in symptoms, with some achieving complete relief from draining tunnels, a common issue in HS. The treatment also eased skin pain and itching, providing quick relief, even for those with severe symptoms. Importantly, these benefits occurred without an increase in side effects compared to other doses. This suggests that povorcitinib holds promise for treating HS, based on data from these studies. ^{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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. investor.incyte.com investor.incyte.com/news-releases/news-release-details/incyte-announces-new-24-week-phase-3-data-stop-hs-clinical-trial

Incyte Announces New 24-Week Phase 3 Data from the ... In both studies, participants receiving povorcitinib 45 mg and 75 mg achieved dt100 (a 100% decrease in draining tunnels from baseline, among ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37871805/

Efficacy and safety of the oral Janus kinase 1 inhibitor ... Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05620836?utm_source=trialradar

NCT05620836 | A Study to Evaluate the Efficacy and ... The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0190962223030372

Efficacy and safety of the oral Janus kinase 1 inhibitor ... Skin pain and itch improvements with povorcitinib were rapid, including for patients with the highest baseline scores. These results are particularly important, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04476043

Study Details | NCT04476043 | To Assess the Efficacy and ... To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06212999

NCT06212999 | A Study to Evaluate the Long-Term Safety ... The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who ...

7. medchemexpress.com medchemexpress.com/povorcitinib.html?srsltid=AfmBOoqCxaibuuJKnqeKAchgKdnNj4oXsBl4EWQh7pqYpFQbGUDkGphr

Povorcitinib (INCB54707) | JAK1 Inhibitor Povorcitinib (60 mg/kg, po, twice daily for 16 days) reduces the serum levels of MCP-1, IP-10, IFN-γ, and TNF-α, reduces the expression of liver injury ...