Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

What Was Tested

In this phase 1 trial, researchers set out to test Octreotide and GHRH (Growth Hormone-Releasing Hormone).

The purpose of the study is to investigate the drug octreotide acetate in a new intranasal formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation.

The two octreotide acetate formulations will be evaluated following separate administrations for safety and tolerability including any side effects, the speed at which the drug is absorbed and eliminated in the body, and the ability of the drug to lower the levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).

It had six arms (groups): Study Part 1 - Arm 1 (experimental), Study Part 1 - Arm 2 (experimental), Study Part 1 - Arm 3 (experimental), Study Part 1 - Arm 4 (experimental) and Study Part 2 - Arm 1 (experimental).

The registry classes the interventions as diagnostic test and drug.

More on the Plan

It inhibits the pathological secretion of GH from pituitary adenomas, and of serotonin and other hormones by tumors of the gastroenteropancreatic endocrine system.

Currently, only injectable octreotide and somatostatin analogs have been approved, for the indications of acromegaly, carcinoid tumors, and vasoactive intestinal peptide tumors.

DP1038, an intranasal formulation of octreotide, is being developed for the treatment of acromegaly, a rare chronic disorder arising from the overproduction of GH, predominantly by pituitary adenomas.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Body mass index (BMI) 18 and \<28 kg/m2 (to minimize variability in SC absorption). Be in good general health.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: subjects will also be excluded if they have a history of gallbladder disease, hypothyroidism, or unexplained hypoglycemia.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-01 with completion listed for 2017-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of subjects reporting adverse events (AEs)/serious adverse events (SAEs) (time frame: Both Study Parts: Entire study duration, an average of 1 week).

It also tracked 10 secondary outcomes, for example Area under the plasma concentration-time curve (AUC), Maximum plasma concentration (Cmax), Time to maximum plasma concentration (Tmax), Lagtime (Tlag), Terminal elimination half-life (t1/2) and Apparent systemic clearance (CL/F).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide and GHRH (Growth Hormone-Releasing Hormone) in 32 people.

Its size is small, so on its own it can only give an early look.

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

More context: the Octreotide compound page and the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.