Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects
Phase 1
- Conditions
- Healthy Japanese male subjects
- Registration Number
- JPRN-jRCT2080222333
- Lead Sponsor
- ihon Medi-Physics Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Body weight: 50.0 kg or more
-Body mass index: 18.5 and more - 25.0 below
Exclusion Criteria
-Subjects with abnormality found by liver function test or renal function test.
-Subjects with a hypersensitive history to drugs or foods.
-Subjects who have abused or are abusing drugs.
-Subjects who were or are addicted to alcohol.
-Subjects who have received an investigational new drug other than NMK20 from six months before screening up to hospital admission.
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Assessment of subjective/objective symptoms, electrocardiogram exams, vital signs, clinical tests
- Secondary Outcome Measures
Name Time Method Pharmacokinetics and exposed dose<br>Pharmacokinetics: 1) Assessment of radioactivity in blood, radioactivity distribution rate in organs/tissue and urinary excretion rate of radioactivity 2) Assessment of unchanged drug and radioactive metabolites in blood plasma and urine<br>Exposed dose: Calculation of exposed dose by medical internal radiation dose(MIRD) method