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Study of INCB123667 for Severe Kidney Impairment

This study is looking at a drug called INCB123667. It aims to understand how safe INCB123667 is and how your body processes it (pharmacokinetics) when you have severe kidney impairment or end-stage renal disease (ESRD). Researchers will give INCB123667 by mouth in one or two doses. The main goal is to measure how much of the drug is in your blood over time. You may be able to join if you are an adult between 18 and 85 years old with severe kidney impairment or ESRD, and meet other health requirements. The study plans to include 16 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 16 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure drug levels in your blood for up to approximately 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07559396

A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease

Recruiting
PHASE1Ages 18–85InterventionalTreatment
Incyte Corporation
~16 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:INCB123667

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PK for plasma INCB123667: Cmax
Measured over Up to approximately 3 months
+2 more outcomes measured

Conditions

Renal Impairment

Explore related trials

Chronic Kidney Disease, Stage 5Severe Renal Impairment

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 18 to 85 years, inclusive, at the time of signing the ICF.
Severe renal impairment or ESRD based on CKD-EPI.
Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
Willingness to avoid pregnancy or fathering children.

Exclusion

Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.
Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.
Tobacco or nicotine-containing product use of \> 10 cigarettes per day within 1 month before screening.
Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.
Participants who have a history of paracentesis within 3 months prior to check-in.
Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.
Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.
Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.

What this trial measures

  • PK for plasma INCB123667: CmaxUp to approximately 3 months

    Defined as the maximum plasma concentration.

  • PK for plasma INCB123667: AUCtUp to approximately 3 months

    Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.

  • PK for plasma INCB123667: AUC∞Up to approximately 3 months

    Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.