Why the study?
The safety, tolerability, and pharmacokinetics of V-7404 following single and multiple ascending oral doses required assessment in healthy adult volunteers.
Is V-7404 safe, tolerable, and what are its pharmacokinetics in healthy adult volunteers?
Is V-7404 safe, tolerable, and what are its pharmacokinetics in healthy adult volunteers?
V-7404 is safe, well-tolerated, and exhibits a predictable pharmacokinetic profile in healthy volunteers, supporting its further development for serious enterovirus infections.
Supports advancing V-7404 to patient studies; extends Phase 1 safety and PK data up to 2000 mg BID.
= 40) study was conducted to assess the safety, tolerability, and pharmacokinetics (PK) of V-7404 in healthy adult volunteers following oral doses starting at 200 mg and escalating to 2,000 mg once daily (QD) and 2,000 mg twice daily (BID). Adverse events (AEs), vital signs, electrocardiographic findings, physical examinations, clinical laboratory values, and PK of blood samples were assessed. No notable differences in demographic and baseline characteristics were observed across the dose cohorts. A total of 35/36 participants (97.2%) completed the SAD study (1 withdrew in the placebo group), and 37/41 participants (90.2%) completed the MAD study (1 withdrew from the 2,000 mg QD and 3 withdrew from the 2,000 mg BID cohorts). No serious AEs or deaths were reported. Treatment-emergent AEs were mild or moderate in severity. Oral doses of V-7404 in all cohorts were readily absorbed and showed no significant accumulation. PK exposure increased in an approximately dose-proportional manner and appeared to be independent of time. Overall, V-7404 was well tolerated and exhibited an acceptable safety and PK profile, supporting further clinical investigation of V-7404 for the treatment of serious EV infections.
No takes yet. Share an insight, caveat, or question.
Kankam et al. (2021) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: