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.

CT.gov Identifier
NCT07559396
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Incyte Corporation
Collaborator
N/A
Study Contact Information
+1 855 446 2983
Recruiting
Contact Us

Study Details

Diseases
Focal Segmental Glomerulosclerosis
Study Drug
INCB-0123667
Genes
N/A
Study Dates
May 2026 - Jan 2027
Sex
Female & Male
Age
18 - 85 Years
Inclusion and Exclusion Criteria
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.

Protocol 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.

Study Locations

To view all trial locations, click here

Contact Us About More Information for the Clinical Trial Concierge Service

Natera’s Clinical Trial Concierge Program is comprised of a dedicated team that helps connect providers and patients with appropriate clinical trials. To learn more about a trial offered through this service, please complete the form below.  

Fields marked with asterisk (*) are mandatory.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.