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An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
This will be an open label study conducted in healthy male participants at a single centre. Each participant will participate in a screening visit and 2 study periods. At the first study period, all participants will receive a single dose of BCT197 and at study period 2, all participants will receive 14 daily doses of itraconazole and a single dose of BCT197.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1 and Period 2 | Other | Period 1 - BCT197 14mg on Day 1 Period 2 - itraconazole 200mg on Day 1 to 14 and BCT197 14mg on Day 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCT197 | Drug | Single dose of BCT197 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measurable Plasma Concentration (Cmax) BCT197 in the presence and absence of itraconazole. | Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7. | Pre-dose to Day 15 |
| Area under the plasma concentration-time curve (AUC) BCT197 in the presence and absence of itraconazole. | Period 1: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose and 1, 2, 4, 6, 12, 24, 36, 48, 72, 96, 144, 168 and 192 hours post BCT197 dose on Day 7. | Pre-dose to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of adverse events during administration of BCT197 alone and in the presence of itraconazole. | Day 1 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected QT interval of the electrocardiogram (QTc). | Period 1: Pre-dose, 2, 4, 6, 8, 24 and 168 hours post BCT197 dose on Day 1. Period 2: Pre-dose, 2, 4, 6, 8, 24, 168 and 192 hours post BCT197 dose on Day 7. | Pre-dose to Day 15 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Parkin, PhD FRCP | Mereo BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| inVentiv Health Clinical Research Services LLC | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| C000710710 | acumapimod |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole 200 mg | Drug | Single dose of itraconazole |
|
|
| D010879 |
| Piperazines |