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
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)
PK for plasma INCB123667: Cmax — Up to approximately 3 months Defined as the maximum plasma concentration.
PK for plasma INCB123667: AUCt — Up to approximately 3 months Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
PK for plasma INCB123667: AUC∞ — Up to approximately 3 months Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
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.
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