This study is for adults whose kidneys do not work well (renal impairment) and adults whose
kidneys work normally. This study will provide more information on a potential new treatment,
called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in
these different groups of people.
This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups
are different in Part 1. In each part, people in the study will stay in a research unit for 6
days and 5 nights. Later, they will return to the research unit for 1 check-up.
In Part 1, people whose kidneys work normally and people whose kidneys work very poorly
(severe renal impairment) can take part.
If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work
well (mild or moderate renal impairment) can take part.
In both parts of the study, people who can take part will be admitted to the research unit.
The next day they will take tablets of ASP0367 just once. People will give blood and urine
samples at various times during their stay. They will have their vital signs (heart rate and
blood pressure) checked regularly. People will also have ECGs to check their heart rhythm.
They will be asked if they have any medical problems. After 6 days, provided all the checks
have been done and there are no medical problems, people in the study will leave the research
People will return to the research unit for 1 check-up. This will be between 9 and 11 days
after their last blood sample was taken during their previous stay in the unit. The check-up
will include a physical exam, a check of people's vital signs (heart rate and blood
pressure), and blood tests. Also, people will have an ECG and be asked if they have had any
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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