A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult… (NCT07559396) | Clinical Trial Compass
RecruitingPhase 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
United States16 participantsStarted 2026-05-29
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on how INCB123667 moves through the body in people with severe kidney disease, rather than on whether it treats a specific condition, what does that mean for any potential personal benefit versus the risks of trying an experimental drug at this stage?
2The trial is specifically measuring how the drug is absorbed and cleared in people with severe renal impairment or end-stage renal disease — given how compromised my kidneys already are, what additional safety risks might come from taking an oral drug that hasn't yet been fully studied in people with my level of kidney function?
3Since this study is primarily collecting pharmacokinetic data like Cmax and AUC to understand drug exposure, how many doses or study visits would I likely need to commit to, and would those visits interfere with my existing kidney disease management or dialysis schedule?
4Are there any standard treatments or already-approved medications relevant to my situation that I should consider before deciding whether participating in a Phase 1 safety and drug-level study like this is the right next step for me?
5Because this trial is still in Phase 1, what is currently known — and what is still unknown — about the safety profile of INCB123667, especially for someone whose kidneys are already severely impaired or failing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.