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Pharmacokinetics of a novel agent, R667, in patients with emphysema
Author(s) -
Chiu YuYuan,
Roth Michael D,
Kolis Stanley,
Rogovitz David,
Davies Brian
Publication year - 2007
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2006.02808.x
Subject(s) - pharmacokinetics , medicine , placebo , dosing , metabolite , pharmacology , pathology , alternative medicine
Aims To evaluate the pharmacokinetics of R667, a novel emphysema agent, in patients with moderate to severe emphysema. Methods Multiple‐dose pharmacokinetics of R667 and its metabolites in emphysematous patients were studied in a multicentre, randomized, single‐blind, and placebo‐controlled trial. Four groups of 10 patients per group received placebo, 0.2, 0.5, or 1 mg R667 once a day for 14–16 days. On day 14 (±1), blood samples were taken at predose and 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 h after dosing. Results Pharmacokinetic analysis of the data indicated that the mean steady‐state C max and AUC(0,τ) of R667 appeared to be dose proportional over the dose range of 0.2–1 mg when administered to emphysematous patients. Mean metabolite to R667 ratios for C max or AUC(0,τ) were, in general, similar across the dose range of 0.2–1 mg. Conclusions The pharmacokinetics of R667 and its metabolites appeared to be similar for patients with emphysema and healthy volunteers. Multiple‐dose administration of 0.2–1 mg of R667 for up to 16 days was well tolerated in patients with emphysema.