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

A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease

This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: INCB123667

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Severe Renal Impairment; Participants with severe renal impairment will be enrolled in Group 1.	Drug: INCB123667; Group 1: Single dose administered orally. Group 2: Two single doses administered orally.
Experimental: Group 2: End Stage Renal Disease; Participants with end stage renal disease will be enrolled in Group 2.	Drug: INCB123667; Group 1: Single dose administered orally. Group 2: Two single doses administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK for plasma INCB123667: Cmax	Defined as the maximum plasma concentration.	Up to approximately 3 months
PK for plasma INCB123667: AUCt	Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.	Up to approximately 3 months
PK for plasma INCB123667: AUC∞	Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.	Up to approximately 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-Emergent Adverse Events (TEAEs)	Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.	Up to approximately 3.5 months

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: end-stage renal disease; Kidney failure; severe renal impairment
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Failure, Chronic
• Other Study ID Numbers: INCB123667-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No