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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1118-5554 | Other Identifier | UTN |
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Primary Objective:
To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503.
Secondary Objective:
To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.
Study duration=17-35 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR302503 | Experimental | single treatment with oral dose up to 300 mg of SAR302503 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR302503 | Drug | Pharmaceutical form:capsule Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: Cmax, AUClast and AUC | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred | 12 days | |
| Safety parameters including Clinical tests | 16 days | |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient'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 Number 840003 | Miami | Florida | 33014 | United States | ||
| Investigational Site Number 840002 |
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| ID | Term |
|---|---|
| C528327 | fedratinib |
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| Safety parameters including laboratory tests |
| 16 days |
| Safety parameters including ECG parameters | 16 days |
| Number of subjects with adverse events (AEs) - Time Frame: | 16 days |
| Orlando |
| Florida |
| 32809 |
| United States |
| Investigational Site Number 840001 | Knoxville | Tennessee | 37920 | United States |