NCT07559396 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
| NCT ID | NCT07559396 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Incyte Corporation |
| Condition | Renal Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2027-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2026-05-29 with a primary completion date of 2027-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Incyte Medical Monitor
STUDY DIRECTOR
Incyte Corporation
Frequently Asked Questions
Who can join the NCT07559396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Renal Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07559396 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07559396 currently recruiting?
Yes, NCT07559396 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT07559396 trial being conducted?
This trial is being conducted at Miami Lakes, United States, Orlando, United States.
Who is sponsoring the NCT07559396 clinical trial?
NCT07559396 is sponsored by Incyte Corporation. The principal investigator is Incyte Medical Monitor at Incyte Corporation. The trial plans to enroll 16 participants.