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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIncyte Corporation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • INCB123667

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators