A Phase 1 interventional study of INCB123667 in Hepatic Insufficiency and Liver Diseases, sponsored by Incyte Corporation. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.
113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.
This study's planned enrollment of 16 is below the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.
Browse Hepatic Insufficiency studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with moderate hepatic impairment will be enrolled in Cohort 1.
Drug: INCB123667
Participants with severe hepatic impairment will be enrolled in Cohort 2.
Drug: INCB123667
single dose administered orally
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUCt
Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUC∞
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
Time frame: Up to approximately 2 months
Number of Treatment-Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.
Time frame: Up to approximately 2.5 months
Plan to share: No
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Studies of the drug tested here: CDK2 Inhibitor INCB123667