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| ID | Type | Description | Link |
|---|---|---|---|
| CA28776 | Other Identifier | Celerion |
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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
| Celerion | INDUSTRY |
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This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: ACH-0145228, Midazolam, and Digoxin | Experimental | Period 1: Participants received single doses of midazolam and digoxin. Period 2: Participants received ACH-0145228 twice daily, in addition to coadministration with single doses of midazolam and digoxin. Scheduled pharmacokinetics (PK) blood and urine samples were collected, with a washout period of at least 7 days between collection of the last PK blood sample in Period 1 and the first dose of ACH-0145228 in Period 2. |
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| Part 2: ACH-0145228 and Itraconazole | Experimental | Period 1: Participants received a single dose of ACH-0145228. Period 2: Participants received itraconazole once daily, in addition to coadministration with a single dose of ACH-0145228. Scheduled PK blood samples were collected, with a washout period of at least 2 days between collection of the last PK blood sample in Period 1 and the first dose of itraconazole in Period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACH-0145228 | Drug | ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228 | Up to 24 hours postdose | |
| Part 1: Maximum Observed Concentration (Cmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228 | Up to 24 hours postdose | |
| Part 1: Time To Maximum Observed Concentration (Tmax) Of Single-dose Midazolam Under Multiple Doses Of ACH-0145228 | Up to 24 hours postdose | |
| Part 1: AUC0-inf Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228 | Up to 168 hours postdose | |
| Part 1: Cmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228 | Up to 168 hours postdose | |
| Part 1: Tmax Of Single-dose Digoxin Under Multiple Doses Of ACH-0145228 | Up to 168 hours postdose | |
| Part 2: AUC0-inf Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole | Up to 96 hours postdose | |
| Part 2: Cmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole | Up to 96 hours postdose | |
| Part 2: Tmax Of Single-dose ACH-0145228 Under Multiple Doses Of Itraconazole | Up to 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number Of Participants With Treatment-emergent Adverse Events (TEAEs) After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Midazolam | Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration) | |
| Part 1: Number Of Participants With TEAEs After Multiple Doses Of ACH-0145228 Coadministered With A Single Dose Of Digoxin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D004077 | Digoxin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Part 1 and Part 2 could be conducted concurrently or separately.
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| Midazolam | Drug | Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup). |
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| Digoxin | Drug | Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet. |
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| Itraconazole | Drug | Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution). |
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| Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration) |
| Part 2: Number Of Participants With TEAEs After A Single Dose Of ACH-0145228 Coadministered With Multiple Doses Of Itraconazole | Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration) |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |