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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Severe Renal Impairment | Experimental | Participants with severe renal impairment will be enrolled in Group 1. |
|
| Group 2: End Stage Renal Disease | Experimental | Participants with end stage renal disease will be enrolled in Group 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB123667 | Drug | Group 1: Single dose administered orally. Group 2: Two single doses administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK for plasma INCB123667: Cmax | Defined as the maximum plasma concentration. | Up to approximately 3 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 3 months |
| PK for plasma INCB123667: AUC∞ | Defined as area under the single-dose concentration-time curve extrapolated to time of infinity. | Up to approximately 3 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 3.5 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 |
|---|---|---|---|---|---|---|
| Floridian Clinical Research | Recruiting | Miami Lakes | Florida | 33016 | 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 Severe Renal Impairment or End Stage Renal Disease | View source |
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| Orlando Clinical Research Center |
| Recruiting |
| Orlando |
| Florida |
| 32809 |
| United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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