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The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASN51 | No Intervention | ||
| ASN51 + Fluvoxamine | Experimental |
| |
| ASN51 + Itraconazole | Experimental |
| |
| ASN51 + Paroxetine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvoxamine | Drug | Oral |
| |
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of ASN51 | Up to Day 15 | |
| Tmax of ASN51 | Up to Day 15 | |
| AUC0-tau of ASN51 | Up to Day 15 | |
| AUC0-inf of ASN51 | Up to Day 15 | |
| t1/2 of ASN51 | Up to Day 15 | |
| λz of ASN51 | Up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to Day 22 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Pokorny, MD | Asceneuron, SA | Study Chair |
| Jeroen v Wetering, MD | QPS Holdings LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Groningen Van Swietenlaan 6 | Groningen | 9728 NZ | Netherlands |
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| ID | Term |
|---|---|
| D016666 | Fluvoxamine |
| D017964 | Itraconazole |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D014230 |
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| Drug |
Oral |
|
| Paroxetine | Drug | Oral |
|
| ASN51 | Drug | Oral |
|
| Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D010880 | Piperidines |