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The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (Midazolam) | Experimental | Single dose of Midazolam 8 mg on Day 1 |
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| Treatment B1 (ACT-132577) | Experimental | Single dose of ACT-132577 150 mg on Day 2; single dose of ACT-132577 50 mg on Day 3, Day 4, and Day 5. |
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| Treatment B2 (Midazolam + ACT-132577) | Experimental | Single dose of Midazolam 8 mg and single dose of ACT-132577 50 mg on Day 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midalozam | Drug | Syrup for oral use |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plama concentration (Cmax) | Cmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577 | Midazolam PK sampling on Days 1, 2, 6 and 7 |
| Area under the plasma concentration-time curve from zero to infinity (AUC0-∞) | AUC0-∞ of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577 | Midazolam PK sampling on Days 1, 2, 6 and 7 |
| Time to reach Cmax (tmax) | Tmax of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577 | Midazolam PK sampling on Days 1, 2, 6 and 7 |
| Terminal half-life (t1/2) | T1/2 of midazolam and 1-hydroxy midazolam following administration of midazolam alone and in combination with ACT-132577 | Midazolam PK sampling on Days 1, 2, 6 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | From Day 1 to Follow-up (for up to 38 days) | |
| Number of subjects with serious adverse events | From Screening to Follow-up (for up to 59 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Newark | New Jersey | 07103 | United States |
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| ID | Term |
|---|---|
| C572762 | aprocitentan |
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| Aprocitentan | Drug | Capsules for oral use |
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