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- W2808813906 abstract "Background This double-blind, first-in-human Phase I study evaluated pharmacokinetics, safety and tolerability of AL-794 (prodrug of ALS-033719), a potent endonucle-ase inhibitor of influenza A and B in healthy volunteers. Methods Healthy adult volunteers were randomized to AL-794 (50–2,000 mg single ascending doses, fasting) or placebo (5 cohorts, n=6:2 AL-794: placebo/cohort) in part 1, and AL-794 (50–600 mg multiple ascending doses, twice-daily, fed or fasted) or placebo (3 cohorts, n=8:2 AL-794: placebo/cohort) for 7 days in part 2. In part 3, 8 healthy volunteers from part 1 received 450 mg AL-794 ( n=6) or placebo ( n=2) following a high-fat meal. All dosing was done with an oral suspension. Blood and urine samples for pharmacokinetics were collected at scheduled times and analysed for ALS-033719 and ALS-033927 (inactive glucuronide) plasma concentrations using LC-MS/MS. Results ALS-033719 plasma concentrations increased dose proportionately up to 150 mg but less than proportionately above 150 mg. Steady-state was generally achieved by the third dose. ALS-033719 exposure increased following administration with a standard meal (19%–33%) or high-fat meal (3–3.6-fold). ALS-033927 was the major metabolite observed. Renal elimination was negligible (0.2%). Seventeen AL-794-treated healthy volunteers reported ≥1 treatment-emergent adverse event (TEAE; part 1: n=6, 24%; part 2: n=11, 69%). The most common TEAEs were headache (part 1: n=3; part 2: n=5) and dizziness (part 1: n=2; part 2: n=6). Conclusions AL-794 up to 200 mg twice daily achieved ALS-033719 exposures which are expected to be efficacious and were generally tolerated. Further studies are planned to characterize safety and antiviral activity." @default.
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- W2808813906 date "2017-10-01" @default.
- W2808813906 modified "2023-10-02" @default.
- W2808813906 title "Phase I Study on Safety and Pharmacokinetics of a Novel Influenza Endonuclease Inhibitor, AL-794 (JNJ-64155806), following Single- and Multiple-Ascending doses in Healthy Adults" @default.
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- W2808813906 doi "https://doi.org/10.3851/imp3244" @default.
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