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This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icalcaprant with Itraconazole | Experimental | Participants will receive oral Icalcaprant with Itraconazole up to 8 days and then followed for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icalcaprant | Drug | Oral capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Icalcaprant | Cmax of Icalcaprant | Up to approximately 14 days |
| Time to Cmax (Tmax) of Icalcaprant | Tmax of Icalcaprant | Up to approximately 14 days |
| Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant | Beta of Icalcaprant | Up to approximately 14 days |
| Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant | T1/2 of Icalcaprant | Up to approximately 14 days |
| Area under the plasma concentration-time curve (AUC) of Icalcaprant | AUC of Icalcaprant | Up to approximately 14 days |
| Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant | AUCt of Icalcaprant | Up to approximately 14 days |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant | AUCinf of Icalcaprant | Up to approximately 14 days |
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 271617 | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole (ITZ) | Drug | Oral capsule |
|
| Up to approximately 47 days |
| D010879 |
| Piperazines |