Phase I study of KRP-AM1977X (Clinical pharmacological study)
Phase 1
Completed
- Conditions
- patients with renal dysfunction
- Registration Number
- JPRN-jRCT2080225074
- Lead Sponsor
- Kyorin Pharmaceutical Co.,Ltd.
- Brief Summary
Decreased renal function had little effect on the blood kinetics of AM-1977 after a single oral dose of KRP-AM1977X 75 mg in the groups with mild, moderate and severe renal impairment. It was considered that AM-1977 showed almost the same kinetics as in the normal group even in patients with decreased renal function. In addition, there was no effect of decreased renal function on the occurrence of adverse events or the results of laboratory tests, etc.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
Person with BMI that is more than 18.5 but less than 30.0, etc.
Exclusion Criteria
Have a history of allergy or severe side effects to quinolone antibiotics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method