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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

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

ArmDescriptionAssigned Intervention
Experimental
Group 1: Severe Renal Impairment 		Participants with severe renal impairment will be enrolled in Group 1.
  • Drug: INCB123667
    Group 1: Single dose administered orally. Group 2: Two single doses administered orally.
Experimental
Group 2: End Stage Renal Disease 		Participants with end stage renal disease will be enrolled in Group 2.
  • Drug: INCB123667
    Group 1: Single dose administered orally. Group 2: Two single doses administered orally.

Recruiting Locations

Floridian Clinical Research
Miami Lakes, Florida 33016

Orlando Clinical Research Center
Orlando, Florida 32809

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.