Atherosclerosis Clinical Trial
Official title:
An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of SB-480848 in Healthy Subjects and in Subjects With Severe Renal Impairment
In accordance with the recently revised FDA draft renal impairment guidance (March 2010)
which advises the conduct of renal impairment study in drugs that are not predominately
eliminated through the renal route, the proposed study will be conducted to formally assess
the pharmacokinetics (PK) of darapladib in severely renally impaired subjects.
In this is an open-label, non-randomized study eight subjects with severe renal impairment
will be recruited along with 8 healthy control subjects matched to the severe renal
impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or
minus 10 years).
All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10
consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and
tolerability will be evaluated.
All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check
out of the clinic on Day 2 after all assessments are complete, but must return to the clinic
each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic again
on the evening of Day 9. After the last dose of the study drug, there will be a follow-up
period which will include 2 visits (Day 20-24 and Day 38-52). The total study duration for
each subject including the screening, treatment and follow-up periods will be approximately
11 weeks.
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