At a glance
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A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-4482 in Healthy Participants Inoculated With Experimental Influenza Virus
In Brief
A Phase 1 clinical trial evaluating Molnupiravir, Placebo molnupiravir, and 3 other interventions for Influenza Infection. Completed, enrolled 161 participants across 1 site.
Detailed Summary
This is a phase 2a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of molnupiravir (MK-4482) in healthy participants inoculated with experimental influenza virus. The primary hypotheses are that MK-4482 initiated 12 hours following intranasal inoculation of the influenza challenge virus reduces the peak viral load compared to placebo and that MK-4482 initiated 2 days following intranasal inoculation of the influenza challenge virus reduces the viral load area under the curve (AUC) compared to placebo.
Study Details
Timeline
Interventions
Four molnupiravir 200 mg capsules (800 mg total dose) taken twice daily by mouth.
Four placebo capsules matched to molnupiravir taken twice daily by mouth.
Placebo capsule matched to oseltamivir taken twice daily by mouth.
One capsule of oseltamivir 75 mg taken twice daily by mouth.
Influenza A challenge virus given once by intranasal administration at an inoculum concentration of between approximately 5 and 7 Log10 tissue culture infective dose 50% (TCID50/mL).