Publications by authors named "John Wallens"
Population pharmacokinetics of teduglutide following repeated subcutaneous administrations in healthy participants and in patients with short bowel syndrome and Crohn's disease.
Jean-Francois Marier Mohamad-Samer Mouksassi Nathalie H Gosselin Martin Beliveau Jane Cyran John Wallens
J Clin Pharmacol
January 2010
Article Synopsis
- * The drug follows a 1-compartment model for absorption, with male participants showing about 18% higher clearance rates compared to females, and body weight significantly impacting the volume of distribution and elimination half-life.
- * No adjustments to dosages are needed for patients with altered kidney or liver function, and the findings will assist in drug labeling and determining if personalized dosing is necessary.
Teduglutide, a glucagon-like peptide-2 (GLP-2) analog, is currently being evaluated for the treatment of short-bowel syndrome, Crohn's disease, and other gastrointestinal disorders. The pharmacokinetics, safety, and tolerability of teduglutide in healthy subjects (N = 64) were assessed following daily subcutaneous administrations for 8 days in a double-blinded, randomized, placebo-controlled, ascending-dose study. Teduglutide treatments were administered as a 50-mg/mL (10, 15, 20, 25, 30, 50, and 80 mg) or 20-mg/mL (20 mg) formulation.
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