A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers

What Was Tested

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

It had 11 arms (groups): ONO-5788 Part A1 (experimental), ONO-5788 Placebo Part A1 (placebo comparator), ONO-5788 Part A2 (experimental), ONO-5788 Placebo Part A2 (placebo comparator) and ONO-5788 Part B (experimental).

The registry classes the interventions as drug.

More on the Plan

Subjects in Part B will have ultrasound scans of the gallbladder during the study and at screening a HIDA scan will be performed.

An evaluation of the PK in the elderly and any potential gender differences will also be evaluated in Part C.

Subjects in Part C will have an ultrasound of the gallbladder at screening.

Part D will be a proof of principle evaluation where the effects of ONO-5788 to inhibit the GHRH and arginine-stimulated GH release will be evaluated.

Who Took Part

The registry lists 76 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Healthy, adult, male and female (women of non-child bearing potential, surgically sterile) volunteers, 18-55 years of age, inclusive, at screening (Parts A \& B only). Healthy, adult, males and female (women of non-child bearing potential), ≥65 years of age at screening (Part C only). Healthy, adult, male, 18-40 years of age, inclusive, at screening (Part D only). Body mass index (BMI) of ≥18.5 to ≤30 kg/m2 at screening (Parts A, B \& C). Body mass index (BMI) of ≥18.5 to \<25 kg/m2 at screening (Part D only).

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: history or presence of hypersensitivity or idiosyncratic reaction to the study drugs,excipients or related compounds; history or presence of:; known diabetes mellitus type 1 or type 2;.

How the Study Was Run

Design: randomized, sequential and quadruple-blind.

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

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

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

It started in 2018-06-07 with completion listed for 2019-05-16.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of participants with treatment emergent adverse events by severity (time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28). Number of participants with serious adverse events (SAEs) (time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28). Number of participants with ECG abnormalities (time frame: Part A - up to day 8; Part B - at least day 21; Part C - at least day 21; and Part D - up to day 28).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 76 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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