Renal Impairment
Conditions
Keywords
severe renal impairment, Kidney failure, end-stage renal disease
Brief 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.
Interventions
DRUGINCB123667
Group 1: Single dose administered orally. Group 2: Two single doses administered orally.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 3.5 months | Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment. |
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed