1. Effect of varying degrees of renal impairment on the pharmacokinetics and tolerability of taspoglutide
- Author
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Mylène, Giraudon, Stefan, Sturm, Nathalie, Lambert, Markus, Niggli, Jochen, Brumm, Bernhard, Mangold, and Christophe, Schmitt
- Subjects
Adult ,Male ,Gastrointestinal Diseases ,Metabolic Clearance Rate ,Middle Aged ,Kidney ,Kidney Function Tests ,Creatinine ,Antibody Formation ,Linear Models ,Humans ,Female ,Renal Insufficiency ,Peptides ,Aged - Abstract
To evaluate single-dose pharmacokinetics and tolerability of taspoglutide in people with varying degrees of renal impairment and matched healthy participants.Participants in the present study were people with mild renal impairment (n = 10), moderate impairment (n = 10), severe impairment (n = 9), and a matched healthy control group (n = 10). Participants received a single subcutaneous injection of taspoglutide (10 mg) on day 1. Plasma and urine drug concentration, antibody formation, vital signs, ECGs and routine laboratory variables were measured frequently and adverse events (AEs) were monitored for 9 weeks.Taspoglutide exposure was higher among participants with moderate and severe renal impairment compared with participants with normal renal function. Mean AUCRenal impairment altered the pharmacokinetics of taspoglutide. The degree of renal impairment was associated with an increased exposure to taspoglutide and an increased risk of GI AEs.
- Published
- 2016