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
Recruiting · NCT07559396 · Interventional (participants receive a specific treatment) · Lead sponsor: Incyte Corporation
View the official record on ClinicalTrials.gov →Interventions studied
INCB123667
What this trial is about
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 take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
- ther protocol-defined Inclusion/Exclusion Criteria may apply.
Where it is running
2 locations listed across 1 US state.
- Floridian Clinical Research - Miami Lakes, Florida, United States
- Orlando Clinical Research Center - Orlando, Florida, United States