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Aims  The aim was to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of octreotide subcutaneous (s.c.) depot, a novel octreotide formulation.    Methods  This was a phase I, randomized, open label study. After a single dose of octreotide immediate release (IR) 200 µg, subjects were randomized to one of eight groups to receive three monthly injections of octreotide s.c. depot A 10, 20 or 30 mg, B 30 mg, C 10, 20 or 30 mg or long acting octreotide (octreotide LAR) 30 mg.    Results  One hundred and twenty‐two subjects were randomized. For all depot variants, onset of octreotide release was rapid and sustained for up to 4 weeks. The relative octreotide bioavailability of depot variants  vs . octreotide IR ranged from 0.68 (90% confidence interval [CI] 0.61, 0.76) to 0.91 (90% CI 0.81, 1.02) and,  vs . octreotide LAR, was approximately four‐ to five‐fold greater: 3.97 (90% CI 3.35, 4.71) to 5.27 ng ml –1  h (90% CI 4.43, 6.27). All depot variants showed relatively rapid initial reductions of insulin‐like growth factor 1 (IGF‐1) compared with octreotide LAR. A trend of octreotide dose dependence was also indicated from the plasma concentrations and suppression of IGF‐1. Maximum inhibition of IGF‐1 at steady‐state was highest for depot B and C. All depot treatments were well tolerated. The most frequent adverse events were gastrointestinal related.    Conclusions  Octreotide s.c. depot provides greater octreotide bioavailability with a more rapid onset and stronger suppression of IGF‐1 than octreotide LAR in healthy volunteers.

Octreotide s.c. depot provides sustained octreotide bioavailability and similar IGF‐1 suppression to octreotide LAR in healthy volunteers