MK-4482 - Healthy | Phase 1 | Merck & Company, Inc. | BiopharmaWatch

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MK-4482

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Apr 16, 2026

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedCONTROLLED

Total Trials2

Total Enrollment80

FDA Designations

No designations recorded

Clinical Trials (2)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT06816030	A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)	PHASE1	COMPLETED	16	—	—	Jun 28, 2023	Aug 5, 2023	Apr 16, 2026	1	China
NCT06615869	A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)	PHASE1	COMPLETED	64	—	—	Jan 20, 2023	Mar 15, 2023	Jul 11, 2025	1	United States

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Study Endpoints

Primary Endpoints

The Maximum Observed Plasma Concentration (Cmax) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

Cmax of N-hydroxycytidine (NHC) after a single oral dose of MK-4482 in period 1.

Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Single Oral Dose of MK-4482 in Period 1.

At designated time points up to 72 hours post-dose

Tmax of NHC following single oral dose of MK-4482 in period 1.

Elimination Half Life (T1/2) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after a single oral dose of MK-4482 in period 1.

Apparent Total Clearance (CL/F) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

CL/F of NHC from plasma after single oral dose of MK-4482 in period 1.

Apparent Volume of Distribution (Vz/F) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

Vz/F of NHC during terminal phase after single oral dose of MK-4482 in period 1.

Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

This is a measure of the average amount of NHC in the plasma over a period of 12 hours after single oral dose of MK-4482 in period 1.

Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

AUC0-last of NHC following a single oral dose of MK-4482 in period 1.

Area Under The Plasma Concentration Versus Time Curve From Time Zero (pre-dose) to Extrapolated Infinite Time (AUC0-inf) After Single Oral Dose of MK-4482 in Period 1

At designated time points up to 72 hours post-dose

AUC0-inf of NHC after single oral dose of MK-4482 in period 1.

The Maximum Observed Plasma Concentration (Cmax) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

Cmax of NHC after multiple oral doses of MK-4482 in period 2.

Time to Reach Maximum Observed Plasma Concentration (Tmax ) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

Tmax of NHC following multiple oral doses of MK-4482 in period 2.

Elimination Half Life (T1/2) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

T1/2 is defined as the time required for the concentration or amount of NHC in the body to be reduced by one-half after multiple oral doses of MK-4482 in period 2.

Clearance at Steady State (CLss/F) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

CLss/F of plasma NHC following multiple doses of MK-4482 in period 2.

Apparent Volume of Distribution (Vz/F) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

Vz/F of NHC during terminal phase after multiple doses of MK-4482 in period 2.

Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC0-12hr) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

This is a measure of the average amount of NHC in the plasma over a period of 12 hours after multiple oral doses of MK-4482 in period 2.

The Minimum Concentration (Ctrough) After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

Ctrough of NHC that occurred following multiple doses of MK-4482 in period 2.

Accumulation Ratio on Cmax After Multiple Oral Doses of MK-4482 in Period 2

At designated time points up to 72 hours post-dose

The maximum concentration at steady state following multiple doses of MK-4482 in period 2 divided by the maximum concentration following the initial dosing in Period 1.

Accumulation Ratio on AUC0-12hr After Multiple Oral Doses of MK-4482

At designated time points up to 72 hours post-dose

The AUC0-12hr at steady state following multiple doses of MK-4482 in period 2 divided by the AUC0-12hr following the initial dosing in Period 1.

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of N-Hydroxycitidine (NHC) in plasma: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

AUC0-inf of NHC in plasma will be determined.

Area Under the Concentration-Time Curve From Time Zero to last measurable timepoint (AUC0-last) of NHC in plasma: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

AUC0-last of NHC in plasma will be determined.

Area Under the Concentration-Time Curve From Time Zero to 12 hours (AUC0-12) of (NHC) in plasma: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 12 hours postdose

AUC0-12 of NHC in plasma will be determined.

Maximum plasma concentration (Cmax) of NHC: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

Cmax of NHC in plasma will be determined.

Time to maximum plasma concentration (Tmax) of NHC: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

Tmax of NHC in plasma will be determined.

Apparent terminal half-life (t1/2) of NHC in plasma: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

t1/2 of NHC in plasma will be determined.

Apparent Clearance (CL/F) of NHC in plasma: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

CL/F of NHC in plasma will be determined.

Apparent volume of distribution during terminal phase (Vz/F) of NHC in plasma: Treatment A versus Treatment B

Pre-dose, and at designated timepoints up to 72 hours postdose

Vz/F of NHC in plasma will be determined.

Secondary Endpoints

Number of Participants Who Experience an Adverse Event (AE)

Up to ~ 5.5 weeks

Number of Participants Who Discontinue Study Treatment Due to an AE

Up to ~ 5.5 weeks

AUC0-inf of NHC in plasma: Treatment B versus Treatment C

Pre-dose, and at designated timepoints up to 72 hours postdose

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Study Design & Arms

AllocationNA

MaskingNONE

ModelSINGLE_GROUP

PurposeBASIC_SCIENCE

Treatment Arms

Arm	Type	Description
MK-4482	EXPERIMENTAL	Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.
Molnupiravir Treatment A	EXPERIMENTAL	Participants receive molnupiravir reference capsule.
Molnupiravir Treatment B	EXPERIMENTAL	Participants receive molnupiravir Formulation 1.
Molnupiravir Treatment C	EXPERIMENTAL	Participants receive molnupiravir Formulation 1 after a high-fat meal.
Molnupiravir Treatment D	EXPERIMENTAL	Participants receive molnupiravir Formulation 2.

Interventions

Name	Type	Description
MK-4482	DRUG	Participants in period 1 received, MK-4482 800 mg single oral dose in the morning on Day 1. Participants in period 2 received, MK-4482 800mg oral dose administered every 12 hours (Q12H) on Day 1 through Day 6 for11 doses.
Molnupiravir	DRUG	Oral Administration.

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Eligibility Criteria

Age Range18 Years — 60 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: \- Has a Body Mass Index (BMI) of 19 to 24 weight (kg)/height (m)2, inclusive, and body weight of ≥ 50 kg at the screening visit. Exclusion Criteria: The main exclusion criteria include but are not limi...

Countries:ChinaUnited States

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