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This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 2: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 3: ACH-0145228 as power-in-capsule under fasted conditions (reference). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
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| Sequence 2 | Experimental | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 2: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 3: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
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| Sequence 3 | Experimental | Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 2: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 3: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). There will be a washout period of at least 5 days between each ACH-0145228 dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACH-0145228: Immediate Release | Drug | ACH-0145228 (240 milligrams) will be administered orally on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule | Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf). | Up to 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose | |
| AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Lincoln | Nebraska | 68502 | United States |
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This will be a 3-sequence, 3-period crossover study in healthy adult participants.
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| ACH-0145228: Powder-in-capsule | Drug | ACH-0145228 (240 milligrams) will be administered orally on Day 1. |
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| Up to 72 hours postdose |
| Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose |
| Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions | Up to 72 hours postdose |
| AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions | Up to 72 hours postdose |
| Number Of Participants With Treatment-emergent Adverse Events | Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration) |