Single and Multiple Dose Study of MK-5475 in Healthy Participants
Phase 1
- Conditions
- Pulmonary Hypertension
- Registration Number
- JPRN-jRCT2031210073
- Lead Sponsor
- Tanaka Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 48
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
Has a history of clinically significant abnormalities or diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Part 1 (Single dose part)<br>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<br>-Part 2 (Multiple dose part)<br>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 Outcome Measures
Name Time Method -Part 1 (Single dose part)<br>AUC0-inf, Cmax, AUC0-24, Tmax and t1/2 following single-dose inhaled administration of MK-5475 in healthy Japanese and Caucasian male participants <br>-Part 2 (Multiple dose part)<br>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