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The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 : Severe hepatic impairment | Experimental | Child Pugh (CP) assessment score of 10-14 points |
|
| Treatment Group 2 : Moderate hepatic impairment | Experimental | Child Pugh (CP) assessment score of 7-9 points |
|
| Treatment Group 3 : Mild hepatic impairment | Experimental | Child Pugh (CP) assessment score of 5-6 points |
|
| Treatment Group 4 : Normal hepatic impairment | Experimental | Normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| parsaclisib | Drug | parsaclisib will be administered orally after 8 hours of fasting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter : Cmax of parsaclisib | Maximum Observed Plasma Concentration of parsaclisib | 5 Days |
| Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib | Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib | 5 Days |
| Pharmacokinetics Parameter : AUC(0-t) of parsaclisib | Area Under the concentration- time curve up to the last measurable concentration of parsaclisib | 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAE) | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | Up to10 Days |
| Pharmacokinetics Parameter : tmax of parsaclisib |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States | ||
| Orange County Research Center |
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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|
Time to reach maximum plasma concentration of parsaclisib
| 5 Days |
| Pharmacokinetics Parameter : t1/2 of parsaclisib | Apparent terminal phase disposition half-life of parsaclisib | 5 Days |
| Pharmacokinetics Parameter : CL/F of parsaclisib | Oral dose clearance of parsaclisib | 5 Days |
| Pharmacokinetics Parameter : Vz/F of parsaclisib | Apparent oral dose volume of distribution of parsaclisib | 5 Days |
| Tustin |
| California |
| 92780 |
| United States |
| Clinical Pharmacology of Miami | Hialeah | Florida | 33014 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| C000656179 | parsaclisib |
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