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Clinical Trials in the USA / NCT07559396
Recruiting Phase 1

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 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2026-05-29
Last updated
2026-06-16

Condition(s) studied

Renal Impairment

Investigational drug(s) / intervention(s)

INCB123667

INCB123667: Group 1: Single dose administered orally. Group 2: Two single doses administered orally.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Floridian Clinical Research Miami Lakes Florida Recruiting
Orlando Clinical Research Center Orlando Florida Recruiting

More Incyte Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07559396 on ClinicalTrials.gov ↗ ← All trials in the USA