Single and Multiple Dose Study of MK-4482 in Healthy Japanese Adults

A Single and Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4482 in Healthy Japanese Adult Participants(COVID-19)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210010

Enrollment

Registered

2021-04-05

Start date

2021-04-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus disease caused by severe acute respiratory syndrome coronavirus 2

Interventions

- Drug: MK-4482 (molnupiravir) MK-4482 100-1600 mg administered orally in capsule form once or twice daily (every 12 hours for 5.5 days, 11 doses in total) - Drug: Placebo Placebo matching MK-4482 adm

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy Japanese male between the ages of 20 and 60 years with BMI of 18.5 to 24.9 kg/m2

Exclusion criteria

Exclusion criteria: Has a history of clinically significant abnormalities or diseases.

Design outcomes

Primary

Measure	Time frame
1. Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations following a single or multiple oral doses of MK-4482 2. Cmax, Tmax, t1/2, AUC0-12, AUC0-last and AUC0-inf of N-hydroxycytidine in plasma following a single oral dose of MK-4482 3. Ctrough, Cmax, Tmax, t1/2, AUC0-tau, accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine following multiple oral doses of MK-4482	—

Measure

Time frame

1. Adverse events, vital signs, laboratory safety tests, 12-lead electrocardiograms, physical examinations following a single or multiple oral doses of MK-4482 2. Cmax, Tmax, t1/2, AUC0-12, AUC0-last and AUC0-inf of N-hydroxycytidine in plasma following a single oral dose of MK-4482 3. Ctrough, Cmax, Tmax, t1/2, AUC0-tau, accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine following multiple oral doses of MK-4482

—

Secondary

Measure	Time frame
1. AUC0-inf and Cmax of N-hydroxycytidine in plasma following a single oral dose of MK-4482 with food 2. Cmax, Tmax, t1/2, AUC0-12, AUC0-last and AUC0-inf of N-hydroxycytidine triphosphate in peripheral blood mononuclear cells following a single oral dose of MK-4482 3. Ctrough, Cmax, Tmax, t1/2, AUC0-tau, accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine triphosphate in peripheral blood mononuclear cells following multiple oral doses of MK-4482	—

Measure

Time frame

1. AUC0-inf and Cmax of N-hydroxycytidine in plasma following a single oral dose of MK-4482 with food 2. Cmax, Tmax, t1/2, AUC0-12, AUC0-last and AUC0-inf of N-hydroxycytidine triphosphate in peripheral blood mononuclear cells following a single oral dose of MK-4482 3. Ctrough, Cmax, Tmax, t1/2, AUC0-tau, accumulation ratio for Cmax and AUC0-tau of N-hydroxycytidine triphosphate in peripheral blood mononuclear cells following multiple oral doses of MK-4482

—

Contacts

Public ContactMSDJRCT inquiry mailbox

MSD K.K.

msdjrct@msd.com+81-3-6272-1957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026