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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-4098 | Registry Identifier | ICTRP | |
| PRN1008-020 | Other Identifier | Sanofi Identifier | |
| POP17091 | Other Identifier | Sanofi Identifier |
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This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilzabrutinib: Mild Hepatic Impairment | Experimental | Subjects with mild Hepatic Impairment (HI) |
|
| Rilzabrutinib: Moderate Hepatic Impairment | Experimental | Subjects with moderate Hepatic Impairment (HI) |
|
| Rilzabrutinib: Healthy-Matched Control | Experimental | Subjects with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilzabrutinib | Drug | Rilzabrutinib tablet administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of total rilzabrutinib in plasma from 0 to t (AUC0-t) | Up to 30 hours after rilzabrutinib dosing | |
| Area under the concentration-time curve of total rilzabrutinib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) | Up to 30 hours after rilzabrutinib dosing | |
| Percent of AUC0-inf extrapolated total rilzabrutinib in plasma (%AUCextrap ) | Up to 30 hours after rilzabrutinib dosing | |
| Maximum measured concentration of total rilzabrutinib in plasma (Cmax) | Up to 30 hours after rilzabrutinib dosing | |
| Time from dosing to maximum measured concentration of total rilzabrutinib in plasma (tmax) | Up to 30 hours after rilzabrutinib dosing | |
| Terminal Half-Life of total rilzabrutinib in Plasma (t1/2) | Up to 30 hours after rilzabrutinib dosing | |
| Elimination Rate Constant of total rilzabrutinib (Kel) | Up to 30 hours after rilzabrutinib dosing | |
| Apparent Total Clearance of rilzabrutinib in the plasma after extra-vascular administration (CL/F) | Up to 30 hours after rilzabrutinib dosing | |
| Apparent Volume of Distribution during the Terminal elimination phase after extravascular administration (Vz/F) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of rilzabrutinib metabolites in plasma from 0 to t (AUC0-t) | Up to 24 hours after rilzabrutinib dosing | |
| Area under the concentration-time curve of rilzabrutinib metabolites in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) |
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Inclusion Criteria:
Hepatic Impaired Subjects:
Healthy Subjects:
Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.
--Weight ≥ 50 kg at screening.
Additional inclusion criteria might apply.
Exclusion Criteria:
Hepatic Impaired Subjects:
Healthy Subjects
Additional exclusion criteria might apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number: 0002 | Miami | Florida | 33014 | United States | ||
| Investigational Site Number: 0001 |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| Up to 30 hours after rilzabrutinib dosing |
| Fraction of unbound drug ( rilzabrutinib) expressed as percent (%fu) | Up to 24 hours after rilzabrutinib dosing |
| Number of Adverse Events (AE) / Serious Adverse Events (SAE) | From date of signed ICF, up to 9 days after rilzabrutinib dosing |
| Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities | Up to 30 hours after rilzabrutinib dosing |
| Up to 24 hours after rilzabrutinib dosing |
| Percent of AUC0-inf extrapolated rilzabrutinib metabolites in plasma (%AUCextrap) | Up to 24 hours after rilzabrutinib dosing |
| Maximum measured concentration of rilzabrutinib metabolites in plasma (Cmax) | Up to 24 hours after rilzabrutinib dosing |
| Time from dosing to maximum measured concentration of rilzabrutinib metabolites in plasma (tmax) | Up to 24 hours after rilzabrutinib dosing |
| Terminal Half-Life of rilzabrutinib metabolites in Plasma (t1/2) | Up to 24 hours after rilzabrutinib dosing |
| Elimination Rate Constant of rilzabrutinib metabolites (Kel) | Up to 24 hours after rilzabrutinib dosing |
| Metabolite-to-parent ratio (MRAUC) | MRAUC is Based on AUC0-t, corrected for Molecular weights (MW). MRAUC = (AUC0-t,M/AUC0-t,P) x (MW,P/MW,M) where M was metabolite and P was parent. | Up to 24 hours after rilzabrutinib dosing |
| Metabolite-to-parent ratio (MRCmax) | MRCmax is based on Cmax, corrected for MW. MRCmax = (Cmax,M/ Cmax,P) x (MW,P/MW,M) where M was metabolite and P was parent. | Up to 24 hours after rilzabrutinib dosing |
| Orlando |
| Florida |
| 32809 |
| United States |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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