MedTrace Logo

Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)

NCT05818124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2025-08-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Influenza Infection

Interventions

DRUG

Molnupiravir

Four molnupiravir 200 mg capsules (800 mg total dose) taken twice daily by mouth.

DRUG

Placebo molnupiravir

Four placebo capsules matched to molnupiravir taken twice daily by mouth.

DRUG

Placebo oseltamivir

Placebo capsule matched to oseltamivir taken twice daily by mouth.

DRUG

Oseltamivir

One capsule of oseltamivir 75 mg taken twice daily by mouth.

BIOLOGICAL

Influenza A Virus

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).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2024-06-28
Completion
2024-06-28
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818124 on ClinicalTrials.gov