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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004226-28 | EudraCT Number |
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The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period A | Experimental | Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 |
|
| Treatment period B | Experimental | Treatment B1: rifampicin followed by Treatment B2: ACT-246475 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Single i.v. infusion of 100 mL saline 0.9% for 30 min |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration |
| AUC from zero to infinity (AUC0-inf) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration |
| The maximum plasma concentration (Cmax) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration |
| The time to reach Cmax (tmax) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration |
| Terminal half-life (t½) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Netherlands B.V. | Groningen | 9700 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32166864 | Result | Schilling U, Dingemanse J, Voors-Pette C, Romeijn C, Dogterom P, Ufer M. Effect of Rifampin-Mediated OATP1B1 and OATP1B3 Transporter Inhibition on the Pharmacokinetics of the P2Y12 Receptor Antagonist Selatogrel. Clin Transl Sci. 2020 Sep;13(5):886-890. doi: 10.1111/cts.12774. Epub 2020 Mar 31. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C000601315 | selatogrel |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| ACT-246475 |
| Drug |
Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions |
|
|
| Rifampicin | Drug | Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min |
|
| D017670 |
| Sodium Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |