Pharmacokinetic study of SK-1405 in subjects with or without hepatic impairment
Phase 1
Completed
- Conditions
- Hepatic impairment
- Registration Number
- JPRN-jRCT2080223781
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Capable of giving written consent to participate in the study from oneself
- BMI: equal to or more than 18.5, and less than 30.0 (exclusive); at the screening
- (Only in subjects with hepatic impairment) Diagnosed to have cirrhosis
etc.
Exclusion Criteria
- Use of contraindicated drug
- History of surgery on digestive disease
- Mental disease
- Severe heart disease
- Severe allergy
- Complication or hisoty of drug dependence
- Habit of excessive drinking of alcohol
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method other<br>- Pharmacokinetics<br>- Drug concentrations<br>- Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method safety<br>- Safety