Key result
A single 100-mg oral dose of sitaxsentan resulted in comparable pharmacokinetic profiles among subjects with normal or varying degrees of impaired renal function.
Why the study?
Does renal impairment affect the pharmacokinetic profile of a single 100-mg oral dose of sitaxsentan?
Population
24 subjects with normal and impaired renal function.
Comparison
Single 100-mg oral dose of sitaxsentan vs Comparison across groups with normal, mild…
Design
Cohort, open label
Authors
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May support no dose adjustment in renal impairment; leaves open confirmation in multiple-dose and outcome trials.
Does renal impairment affect the pharmacokinetic profile of a single 100-mg oral dose of sitaxsentan?
The pharmacokinetic profile of a single 100-mg oral dose of sitaxsentan is unchanged in subjects with varying degrees of renal impairment, suggesting no dose adjustment is necessary.
Dhaun et al. (2007) studied Renal impairment (n=24). Sitaxsentan vs. Normal renal function group was evaluated on Pharmacokinetic profile (Cmax, AUC∞, oral clearance, volume of distribution, elimination half-life). A single 100-mg oral dose of sitaxsentan resulted in comparable pharmacokinetic profiles among subjects with normal or varying degrees of impaired renal function.
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