A Single-dose Study of Octreotide Injection in Healthy Adult Subjects

What Was Tested

This registered phase 1 trial tested Octreotide.

It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

This single centre study will be comprised of 6 cohorts.

Who Took Part

56 actual participants took part.

It was open to people of any sex aged from 22 years up to 45 years.

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

Examples of who could join: Healthy, adult, male and female subjects, 22-45 years of age, inclusive, at screening;. Body weight≥50 kg in male subjects or≥45 kg in female subjects, with BMI 19.0 - 28.0 kg/m\^2 (inclusive);. No clinically relevant findings in the physical examination, ECG, abdominal ultrasonography, vital signs, laboratory examination by investigator's assessment;. Informed consent documents signed by subjects prior the study, and subjects could be able to read, comprehend the procedure or the adverse reaction about the trial;.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: the female subject of childbearing potential, is pregnant (as based on test results in the screening period) or is breast feeding;; the subject with any one of hbsag, hepatitis c antibody, anti-hiv antibody and antibody of treponema pallidum positive;; the subject has a history of acupuncture syncope or blood phobia, or has difficulty with vein blood collection or venipuncture;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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, care provider, investigator and outcomes assessor.

It started in 2023-03-02 with completion listed for 2023-06-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence and severity of adverse events (time frame: Throughout the study period, with an average of 60 days).

It also tracked 7 secondary outcomes, for example Area under the plasma concentration-time curve (AUC), Maximum plasma concentration (Cmax), Time to maximum plasma concentration (Tmax), Terminal elimination half-life (t1/2), Apparent systemic clearance (CL/F) and Apparent volume of distribution (Vz/F).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 56 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.