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
Purpose
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.
Condition
- Renal Impairment
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1: Severe Renal Impairment |
Participants with severe renal impairment will be enrolled in Group 1. |
|
|
Experimental Group 2: End Stage Renal Disease |
Participants with end stage renal disease will be enrolled in Group 2. |
|
Recruiting Locations
Floridian Clinical Research
Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
Orlando Clinical Research Center
Orlando, Florida 32809
Orlando, Florida 32809
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation