Single and Multiple Dose Study of MK-5475 in Healthy Participants

A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-5475 in Healthy Japanese and Caucasian Participants

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210073

Enrollment

Registered

2021-05-10

Start date

2021-05-26

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

Pulmonary Hypertension

Interventions

-Part 1 (Single dose part) Single inhaled dose of MK-5475 32, 100 and 380 ug, or matching placebo will be administerd in period 1, 2 and 3 respectively. -Part 2 (Multiple dose part) Multiple inhaled d

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy Japanese or Caucasian male participants between the ages of 20 and 45 years (inclusive) with a BMI less than or equal to 30 kg/m2.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
-Part 1 (Single dose part) Physical examinations, vital signs, 12-lead electrocardiograms, safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) and adverse events following single-dose inhaled administration of MK-5475 in healthy Japanese and Caucasian male participants -Part 2 (Multiple dose part) Physical examinations, vital signs, 12-lead electrocardiograms, safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) and adverse events following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants	—

Measure

Time frame

-Part 1 (Single dose part) Physical examinations, vital signs, 12-lead electrocardiograms, safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) and adverse events following single-dose inhaled administration of MK-5475 in healthy Japanese and Caucasian male participants -Part 2 (Multiple dose part) Physical examinations, vital signs, 12-lead electrocardiograms, safety laboratory tests (Hematology, Chemistry, Coagulation and Urinalysis) and adverse events following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants

—

Secondary

Measure	Time frame
-Part 1 (Single dose part) AUC0-inf, Cmax, AUC0-24, Tmax and t1/2 following single-dose inhaled administration of MK-5475 in healthy Japanese and Caucasian male participants -Part 2 (Multiple dose part) AUC0-inf, Cmax, AUC0-24, Tmax, t1/2 and accumulation ratio based on Cmax and AUC0-24 following once daily multiple-dose inhaled administration of MK-5475 in healthy Japanese male participants	—

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