ITF2984 Repeated Doses Study in Healthy Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Octreotide.

The study was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised design, each consisting of 12 subjects.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 46 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy Caucasian male volunteers between 18 and 50 years of age, inclusive. Body mass index (BMI) of 18 to 25 kg/m2 inclusive. Was willing and able to communicate and participate in the entire study. Had an understanding, ability and willingness to fully comply with study procedures and restrictions.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: subjects who had received prohibited medication; known or suspected intolerance or hypersensitivity to the imp, closely related compounds or any of the stated ingredients; history of alcohol or other substance abuse within the last year. a positive result for alcohol or drugs of abuse.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2012-01 with completion listed for 2012-09.

It ran at 2 sites in Italy (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To evaluate the effects of ITF2984 on GH, insulin, glucagon and glucose after exogenous stimulus (time frame: 7 days). to evaluate the effects of ITF2984 on TSH, ACTH, Cortisol, PRL, LH and FSH after exogenous stimulus (time frame: 7 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 46 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.