Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL-794 · 3 trials · 2 indications
Safety data including but not limited to tabulation of adverse events, physical exam, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urinalysis). Note that in the Multiple Ascending Dose (MAD) portion of the study, the time frame is from Screening to Day 17 (MAD) and for the Viral Challenge portion of the study the time frame is from Screening to Day 28 (Viral Challenge).
| Arm | Type | Description |
|---|---|---|
| Oseltamivir and AL-794 | OTHER | Oseltamivir alone and with AL-794 over fourteen days. |
| Digoxin, Midazolam, and AL-794 | OTHER | Single doses of Digoxin and Midazolam with and without AL-794 over seventeen days. |
| Pitavastatin and AL-794 | OTHER | Single doses of Pitavastatin with and without AL-794 over seventeen days. |
| JNJ-63623872 and AL-794 | OTHER | JNJ-63623872 alone and with AL-794 over fourteen days. |
| 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 |
| AL-794 | EXPERIMENTAL | AL-794 administered orally in a suspension |
| Vehicle | PLACEBO_COMPARATOR | Suspension vehicle alone |
| Name | Type | Description |
|---|---|---|
| AL-794 | DRUG | - |
| Oseltamivir | DRUG | - |
| Digoxin | DRUG | - |
| Midazolam | DRUG | - |
| Pitavastatin | DRUG | - |
| JNJ-63623872 | DRUG | - |
| AL-794 suspension | DRUG | - |
| AL-794 tablet | DRUG | - |
| Placebo/Vehicle | OTHER | Suspension vehicle without active drug |
Inclusion Criteria: 1. Subject has provided written consent. 2. In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned. 3. Subject is in good health as deem...
AL-794 is an investigational small molecule being developed for the treatment of influenza in humans. It is currently in Phase 1 clinical development, with studies evaluating its safety, tolerability, pharmacokinetics, and antiviral activity in healthy volunteers and in an influenza challenge model.
AL-794 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetic profile in healthy subjects.
AL-794 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three Phase 1 trials have been completed, with a total enrollment of 183 participants, all conducted in the United Kingdom.
AL-794 has completed three Phase 1 clinical trials: NCT02588521, a single and multiple dose study with an influenza challenge component; NCT02877160, a pharmacokinetic study of different formulations; and NCT02888327, a drug-drug interaction study with oseltamivir and JNJ-63623872. All trials were conducted in the United Kingdom.
No, AL-794 is not the same as oseltamivir. AL-794 is a separate investigational drug being developed by Vertex Pharmaceuticals. A completed clinical trial (NCT02888327) specifically evaluated the drug-drug interaction between AL-794 and oseltamivir, indicating they are distinct compounds that may be used together.