A Study in Healthy Subjects to Assess the Safety, Tolerability, PK and PD of HTL0030310

What Was Tested

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

It had three arms (groups): one (experimental), Part 2 Pasireotide PD Assessment (experimental) and one (experimental).

Eight subjects in up to 8 cohorts will be dosed. A single subcutaneous injection of HTL0030310 or placebo will be administered. In each cohort, 6 subjects will receive HTL0030310 and 2 subjects will receive placebo.

Up to 80 subjects in 4 cohorts (up to 20 subjects per cohort) will be dosed in up to 3 study periods. In each period, subjects will receive active drug or placebo with GHRH, OGTT and CRH with desmopressin (optional).

The registry classes the interventions as drug.

More on the Plan

The challenge agents administered in this study will be: oral glucose tolerance test (OGTT), Growth hormone-releasing hormone (GHRH), and corticotrophin releasing hormone (CRH) combined with desmopressin.

Who Took Part

The registry lists 42 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: Age 18 to 50 years of age. A BMI of 20.0 to 30.0 kg/m2, with a minimum weight of 45 kg. Must be willing and able to communicate and participate in the whole study. Must provide written informed consent. Must agree to adhere to the contraception requirements defined in the protocol (Section 9.4).

The full record lists 6 inclusion and 26 exclusion criteria; among the exclusions: subjects who have received any imp in a clinical research study within the previous 3 months of screening; history of any drug or alcohol abuse in the past 2 years; current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.

How the Study Was Run

Design: randomized, sequential and double-blind.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2019-01-23 with completion listed for 2020-03-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Part 1: Number of treatment related adverse events (as determined by abnormal clinical laboratory tests, vitals signs, ECG parameters, Holter ECG parameters and injection site reactions). Part 2 and Part 3 Area under the effect time curve (EAUC) 1) for insulin, glucose, glucagon, GLP1, C-peptide and GIP level 2) for GH 3) ACTH and cortisol. Part 2 and Part 3 Maximum observed effect (EMax) 1) for insulin, glucose, glucagon, GLP1, C-peptide and GIP level 2) for GH 3) ACTH and cortisol.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Pasireotide in 42 people.

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

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