Safety and blood levels of INCB123667 in adults with severe kidney problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial to evaluate the safety profile and pharmacokinetics of the oral drug INCB123667 in adults with severe renal impairment or ESRD. Participants will be monitored for adverse events, laboratory changes, and drug exposure over a defined period. The study helps determine appropriate dosing considerations in this population. It is conducted at two sites in Florida and involves strict eligibility criteria focusing on renal function and overall health status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Floridian Clinical Research
  Miami Lakes, Florida, United States Recruiting
• Orlando Clinical Research Center
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.