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| Name | Class |
|---|---|
| Janssen Biotech, Inc. | INDUSTRY |
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The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprocitentan | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprocitentan 25mg | Drug | Oral tablets in strength of 25 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax during the first and last dosing interval | From study treatment administration to 216 hours after last administration | |
| Time to reach Cmax (tmax) during the first and last dosing interval | From study treatment administration to 216 hours after last administration | |
| AUCÏ„ on the first and last day of study treatment intake | From study treatment administration to 216 hours after last administration |
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Inclusion Criteria:
Negative serum pregnancy test at Screening,
Negative urine pregnancy test on Day -1,
Agreement to consistently and correctly use a reliable method of contraception from Screening up to at least 30 days after last study treatment administration
Japanese subjects only
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| C572762 | aprocitentan |
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| Placebo |
| Drug |
Oral tablets matching aprocitentan tablets |
|