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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Moderate hepatic function | Experimental | Participants with moderate hepatic impairment will be enrolled in Cohort 1. |
|
| Cohort 2: Severe hepatic function | Experimental | Participants with severe hepatic impairment will be enrolled in Cohort 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB123667 | Drug | single dose administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK for plasma INCB123667: Cmax | Defined as the maximum plasma concentration. | 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. | 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. | Up to approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 2.5 months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Trials - the Institute For Liver Health | Recruiting | Chandler | Arizona | 85225 | United States | |
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| Label | URL |
|---|---|
| A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment | View source |
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| Orlando Clinical Research Center |
| Recruiting |
| Orlando |
| Florida |
| 32809 |
| United States |
| Texas Liver Institute - American Research Corporation | Recruiting | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research | Recruiting | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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