Recruiting
Phase 1

INCB123667

Sponsor:

Incyte Corporation

Code:

NCT07559396

Conditions

Renal Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

INCB123667

Study Details

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

Study ID

NCT07559396

Start date

May 29, 2026

Status verified date

Jun, 2026

Completion date

Jan 4, 2027

Anticipated

Primary completion date

Jan 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Severe Renal Impairment

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

experimental: Group 2: End Stage Renal Disease

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

Interventions

INCB123667

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

Primary outcome measure

  • PK for plasma INCB123667: Cmax [ Time Frame: Up to approximately 3 months ]
  • PK for plasma INCB123667: AUCt [ Time Frame: Up to approximately 3 months ]
  • PK for plasma INCB123667: AUC∞ [ Time Frame: Up to approximately 3 months ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Floridian Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33016

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

More Information

Sponsor

Incyte Corporation

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-06-16.