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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-4526 | Other Identifier | UTN | |
| PRN1008-25 | Other Identifier | Principia Biopharma |
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Primary Objective:
Secondary Objective:
- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions
The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive caplets after fast (treatment A) on Day 1 and caplets after meal (treatment B) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. |
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| Group 2 | Experimental | Participants will receive caplets after meal (treatment B) on Day 1 and caplets after fast (treatment A) on day 6, and then receive either oral formulation 1 tablets after fast (treatment C) or oral formulation 2 tablets after fast (treatment D) on day 11. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rilzabrutinib SAR444671 | Drug | Pharmaceutical form: caplet Route of administration: oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax | maximun plasma concentration | From Day 1 to Day 7 |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax | time to maximum plasma concentration | From Day 1 to Day 7 |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last | area under the plasma concentration-time curve from zero to the last measurable concentration | From Day 1 to Day 7 |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf | area under the plasma concentration-time curve from zero to infinity | From Day 1 to Day 7 |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life | terminal elimination phase half-life | From Day 1 to Day 7 |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax | maximun plasma concentration | From Day 11 to Day 12 |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent AE and treatment-emergent SAE | Until Day 15 |
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Inclusion criteria :
- Participants who are overtly healthy as determined by medical evaluation
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Adelaide | 5000 | Australia |
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| Label | URL |
|---|---|
| PKM17098 Plain Language Results Summary | View source |
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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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| rilzabrutinib SAR444671 | Drug | Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral |
|
| rilzabrutinib SAR444671 | Drug | Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral |
|
time to maximum plasma concentration |
| From Day 11 to Day 12 |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last | area under the plasma concentration-time curve from zero to the last measurable concentration | From Day 11 to Day 12 |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf | area under the plasma concentration-time curve from zero to infinity | From Day 11 to Day 12 |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life | terminal elimination phase half-life | From Day 11 to Day 12 |