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The primary objective of the study is to evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme [CYP]3A inhibitor) on the pharmacokinetics of IW-1973.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IW-1973 | Drug | Oral Tablet |
| |
| Itraconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf]) | Predose and up to 14 days post dose of IW-1973 | |
| Maximum Observed Plasma Concentration (Cmax) of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (Tmax) of IW-1973 | Predose and up to 14 days post dose of IW-1973 | |
| Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IQVIA | Overland Park | Kansas | 66211 | United States |
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| ID | Term |
|---|---|
| C000631485 | praliciguat |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Oral Capsule |
|
| Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
| Apparent Terminal Half-Life (t1/2) of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
| Apparent Terminal Rate Constant (lambda[z]) of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
| Apparent Total Plasma Clearance (CL/F) of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
| Apparent Volume of Distribution (Vz/F) of IW-1973 | Predose and up to 14 days post dose of IW-1973 |
| D010879 |
| Piperazines |