A first-in-man study to evaluate the safety, tolerability, and pharmacokinetics of pasireotide (SOM230), a multireceptor-targeted somatostatin analog, in healthy volunteers

What Was Tested

The paper reports a study of Somatostatin and Pasireotide, published as a randomized controlled trial.

Pasireotide (SOM230) is a multireceptor-targeted somatostatin analog with high binding affinity for four of the five somatostatin receptor subtypes (sst(1,2,3) and sst(5)), and potential clinical activity in several neuroendocrine and oncologic conditions, including acromegaly, Cushing's disease, and neuroendocrine tumors (NET).

Seventy-two subjects completed the study.

Who Took Part

PubMed indexes the participants as teenagers and adults, men only.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Somatostatin, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Somatostatin could be set against what happens without it.

Growth hormone (GH) suppression was evaluated using a GH-releasing hormone stimulation test on Day -1 and Day 1 at 3-5 hours post-injection.

What Was Measured

Topics PubMed links to this paper include Area Under Curve, Human Growth Hormone and Somatostatin.

Author keywords: healthy volunteers, pasireotide, safety and tolerability.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Somatostatin and Pasireotide.

The publication is from 2012 (Drug design, development and therapy), a journal based in New Zealand.

More context: the Somatostatin compound page and the Pasireotide compound page, all human trials.