NCT07559396

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
5mo left

Started May 2026

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
May 2026Jan 2027

First Submitted

Initial submission to the registry

April 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

May 29, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2027

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

April 24, 2026

Last Update Submit

June 12, 2026

Conditions

Renal Impairment

Keywords

severe renal impairmentKidney failureend-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

INCB123667DRUG

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

Group 1: Severe Renal ImpairmentGroup 2: End Stage Renal Disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Renal InsufficiencyKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRenal Insufficiency, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Incyte Medical Monitor

    Incyte Corporation

    STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423eumedinfo@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

May 29, 2026

Primary Completion (Estimated)

January 4, 2027

Study Completion (Estimated)

January 4, 2027

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)