Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: A randomized, multicenter, open-label, phase I study. - 2014
[en] Pasireotide (SOM230), a multireceptor-targeted somatostatin analogue, has exhibited favorable safety/tolerability in several clinical studies. A long-acting-release (LAR) formulation of pasireotide may offer advantages over the subcutaneous formulation. This randomized, open-label, Phase I study evaluated the safety, PK, and PD of pasireotide LAR 20, 40, or 60 mg/month in patients with acromegaly. Safety assessments and blood samples for PK and PD were taken at designated time points. Thirty-five patients were randomized and completed the study. Steady-state pasireotide concentrations were achieved following three monthly injections. Trough pasireotide concentrations (ng/mL) 28 days after each injection were: 2.48, 4.16, and 3.10 (20 mg group); 6.42, 6.62, and 7.12 (40 mg group); and 9.51, 11.7, and 13.0 (60 mg group). At study end, 51% and 57% of patients achieved GH levels
Disciplines :
Endocrinology, metabolism & nutrition
Author, co-author :
Petersenn, Stephan
Bollerslev, Jens
Arafat, Ayman M.
Schopohl, Jochen
Serri, Omar
Katznelson, Laurence
Lasher, Janet
Hughes, Gareth
Hu, Ke
Shen, George
Resendiz, Karina Hermosillo
Giannone, Vanessa
Beckers, Albert ; Université de Liège - ULiège > Département des sciences cliniques > Endocrinologie
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