Healthy Clinical Trial
Official title:
A Phase I Study Assessing the Effects of Rifampin on the Pharmacokinetics of Ataluren in Healthy Subjects
This will be a single centre, Phase I, open-label, one cohort, one dose level, fixed-sequence, drug interaction study in healthy volunteers. The objective of this study is to determine the effects of rifampin on the pharmacokinetics of ataluren under fasting conditions.
A total of 15 healthy, adult, male non-smokers, were included in this study. Subjects were
administered ataluren on Day 1 followed by rifampin from Days 3 to12, and again ataluren on
Day 11. On Day 11, ataluren was administered before rifampin administration.
Prior to entering the trial, subjects had a screening visit to establish eligibility within
28 days before study drug administration. Subjects were confined from at least10 hours before
the first ataluren dosing on Day 1 until approximately 50 hours postdose(Day 3). Thereafter,
subjects came back every morning from Days 4 to 10 for rifampin dosing. Then, subjects
reported to the clinical site at least 10 hours before ataluren dosing on Day 11 (evening of
Day 10) and remained in the clinical site until after 50 hours post-Day 11 ataluren dose (Day
13).
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