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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis. Blood sampling for PK assessment will include measures for acoramidis and its metabolite, acoramidis acyl glucuronide (acoramidis-AG).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Acoramidis | Experimental | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fasted conditions. Period 2: Acoramidis as an immediate-release tablet under fed conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
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| Sequence 2: Acoramidis | Experimental | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fed conditions. Period 2: Acoramidis as an immediate-release tablet under fasted conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoramidis | Drug | Film-coated immediate release oral tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions | Up to 336 hours postdose | |
| Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions | Up to 336 hours postdose | |
| Area Under The Plasma Concentration Versus Time Curve From Zero To Infinity (AUC0-inf) For Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions | Up to 336 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax Of Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions | Up to 336 hours postdose | |
| AUC0-t For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions | Up to 336 hours postdose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C000731204 | attruby |
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This will be a balanced, 2-period, 2-sequence, 2-way crossover study in healthy participants. All participants will receive 1 treatment in each period.
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| AUC0-inf For Acoramidis-AG: Fed (Test) Versus Fasted (Reference) Conditions | Up to 336 hours postdose |