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

NCT07559396 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB123667-105
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Renal Impairment

Keywords

severe renal impairment; Kidney failure; end-stage renal disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 3.5 months

Study Arms (2)

Group 1: Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment will be enrolled in Group 1.

Drug: INCB123667

Group 2: End Stage Renal Disease

EXPERIMENTAL

Participants with end stage renal disease will be enrolled in Group 2.

Drug: INCB123667

Interventions

INCB123667 DRUG

Group 1: Single dose administered orally. Group 2: Two single doses administered orally.

Group 1: Severe Renal Impairment; Group 2: End Stage Renal Disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share