Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

What Was Tested

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

It had two arms (groups): Period 1 (experimental) and Period 2 (other).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Healthy males or females ≥18 to ≤55 years of age. Body mass index 18.0 to 32.0 kg/m2, inclusive, at Screening. Willing to adhere to the prohibitions and restrictions specified in this protocol. Able to comprehend and willing to sign an Informed Consent Form.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: prior exposure to telotristat etiprate; use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to screening and for the duration of the study; history of any major surgery within 6 months prior to screening.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-07 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Plasma concentrations of telotristat ethyl (time frame: Days 1, 2, 3, 6, 7, 8). Plasma concentrations of metabolite LP-778902 (time frame: Days 1, 2, 3, 6, 7, 8).

It also tracked 1 secondary outcome, for example Number of treatment-emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Octreotide in 24 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, all human trials.