Phase I study of KRP-AM1977X (Clinical pharmacology study)
Phase 1
Completed
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-jRCT2080222496
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
The AM-1977 concentration in the ELF and AMs was higher than that in plasma. It was considered that AM-1977 had good tarnslocation to the ELF and AMs. In the safety assessment, no major problem was observed in KRP-AM1977X.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 31
Inclusion Criteria
Japanese healthy adult male
- Never smoker, etc.
Exclusion Criteria
- Healthy volunteer Person with a medical history, surgergicaly history and disease that are unsuitable for clinical trials
- An excessive drinker or a person who cannot stop drinking during a rule period, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>Pharmacokinetics<br>The concentration of AM-1977 in bronchoalveolar lavage fluid and alveolar macrophage
- Secondary Outcome Measures
Name Time Method safety<br>Safety<br>Adverse events and side effects