Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal renal function and participants with renal impairment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treat Group 1 : Normal Renal Function | Experimental | eGFR: ≥ 90 mL/min/1.73 m^2 |
|
| Treat Group 2 : Mild Renal Impairment | Experimental | eGFR: 60-89 mL/min/1.73 m^2 |
|
| Treat Group 3 : Moderate Renal Impairment | Experimental | eGFR: 30-59 mL/min/1.73 m^2 |
|
| Treat Group 4 : Severe Renal Impairment | Experimental | eGFR: 15-29 mL/min/1.73 m^2 and not on Hemo Dialysis |
|
| Treat Group 5 : Kidney Failure | Experimental | eGFR: < 15 mL/min/1.73 m^2 on Hemo Dialysis |
|
| 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 Groups1-4 : Cmax of parsaclisib | Maximum Observed Plasma Concentration of parsaclisib | 4 Days |
| Pharmacokinetics Parameter Groups 1-4 : AUC 0-∞ of parsaclisib | Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib | 4 Days |
| Pharmacokinetics Parameter Groups 1-4 : AUC(0-t) of parsaclisib | Area Under the concentration- time curve up to the last measurable concentration of parsaclisib | 4 Days |
| Pharmacokinetics Parameter Group 5: Cmax of parsaclisib | Maximum Observed Plasma Concentration of parsaclisib | 4 Days for period 1 and 2 |
| Pharmacokinetics Parameter Group 5 : AUC 0-∞ of parsaclisib | Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib | 4 Days for period 1 and 2 |
| Pharmacokinetics Parameter Group 5: AUC(0-t) of parsaclisib | Area Under the concentration- time curve up to the last measurable concentration of parsaclisib | 4 Days for period 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4 | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | up to 11 Days |
| Pharmacokinetics Parameter Groups 1-4 : tmax of parsaclisib |
Not provided
Inclusion Criteria:
Participants will be classified at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5).
Participants eligible for Group 5 with ESRD have received HD for at least 3 months prior to screening.
Participants eligible for Group 1 should be in good health as determined by no clinically significant deviations from normal for medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at screening or Day -1.
Participants eligible for Groups 2 through 5 may have medical findings consistent with their degree of renal dysfunction.
Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
0Body mass index within the range 18.0 to 40.0 kg/m2 (inclusive) at screening.
Willingness to avoid pregnancy or fathering children.
Ability to swallow and retain oral medication.
Exclusion Criteria:
Participants eligible for Group 1 who have used tobacco- or nicotine-containing products within 6 months of screening.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Clinical Pharmacology of Miami |
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.
Not provided
| ID | Term |
|---|---|
| C000656179 | parsaclisib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open Label
Not provided
|
Time to reach maximum plasma concentration of parsaclisib |
| 4 Days |
| Pharmacokinetics Parameter Groups 1-4 : t1/2 of parsaclisib | Apparent terminal phase disposition half-life of parsaclisib | 4 Days |
| Pharmacokinetics Parameter Groups 1-4 : CL/F of parsaclisib | Oral dose clearance of parsaclisib | 4 Days |
| Pharmacokinetics Parameter Groups 1-4 : Vz/F of parsaclisib | Apparent oral dose volume of distribution of parsaclisib | 4 Days |
| Pharmacokinetics Parameter Group 5 : tmax of parsaclisib | Time to reach maximum plasma concentration of parsaclisib | 4 Days for period 1 and 2 |
| Pharmacokinetics Parameter Group 5 : t1/2 of parsaclisib | Apparent terminal phase disposition half-life of parsaclisib | 4 Days for period 1 and 2 |
| Pharmacokinetics Parameter Group 5 : CL/F of parsaclisib | Oral dose clearance of parsaclisib | 4 Days for period 1 and 2 |
| Pharmacokinetics Parameter Group 5 : Vz/F of parsaclisib | Apparent oral dose volume of distribution of parsaclisib | 4 Days for period 1 and 2 |
| Pharmacokinetics Parameter Group 5 during Dialysis - : AUC1-5 of parsaclisib | Area Under the Concentration-time Curve From 1 to 5 hrs. of parsaclisib | 4 Days for period 1 and 2 |
| Number of Treatment Emergent Adverse Events (TEAE) Group 5 | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | up to 18 Days |
| Hialeah |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| Prism Research | Saint Paul | Minnesota | 55114 | United States |