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To evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics (PK) of olinciguat
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Period 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olinciguat | Drug | Oral Tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of olinciguat | Predose and up to 8 days post first olinciguat dose | |
| Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf) | Predose and up to 8 days post first olinciguat dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2 | 51 days post first olinciguat dose | |
| Cmax of Itraconazole | First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bina Tejura, MD | Cyclerion Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD | Austin | Texas | 78744 | United States |
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| Itraconazole | Drug | Oral Capsule |
|
| Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole | Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose |
| Cmax of hydroxy-Itraconazole | First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days) |
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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