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This study is a single-center, randomized, open-label crossover study to assess the pharmacokinetics and food effect of AL-794 formulations in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Formulation Fasted | Experimental | 150 mg of AL-794 study drug in suspension dosed in a fasted condition |
|
| Test Formulation Fasted | Experimental | 150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fasted condition |
|
| Test Formulation Fed | Experimental | 150 mg of AL-794 tablet formulation (3 x 50 mg tabs) dosed in a fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-794 suspension | Drug |
| ||
| AL-794 tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time of dosing to infinity (AUC0-inf) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions. | From Day 1 (Prior to dosing) to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as determined by AEs | From screening to Day 14 | |
| Safety as determined by Clinical lab results | From screening to Day 14 | |
| Safety as determined by 12-lead ECGs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adeep Puri | HMR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research Ltd (HMR) | London | United Kingdom |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C038978 | sfericase |
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|
| From screening to Day 14 |
| Safety as determined by Vital signs | From screening to Day 14 |
| Safety as determined by Physical examinations | From screening to Day 14 |
| Maximum observed concentration (Cmax) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions. | From Day 1 (Prior to dosing) to Day 14 |
| Area under the concentration-time curve from time of dosing to last quantifiable concentration (AUC0-last) of ALS-033719 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions. | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: time of the maximum concentration (tmax) | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: terminal elimination half-life (t1/2) | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: Cmax | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: tmax | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: t1/2 | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: AUC0-inf | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033927 in plasma following single dose administration of test formulation and reference formulation of AL-794 under fasted conditions: AUC0-last | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: Cmax | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: Tmax | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: AUC 0-inf | From Day 1 (Prior to dosing) to Day 14 |
| PK parameters of ALS-033719 and ALS-033927 in plasma after a single oral dose of test formulation under fed conditions: AUC 0-last | From Day 1 (Prior to dosing) to Day 14 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |