Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly

What Was Tested

This registered phase 1, phase 2 trial tested Lanreotide.

It had 1 arm (groups): lanreotide PRF (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Documented diagnosis of acromegaly. Provided written informed consent prior to any study related procedures. Between 18 and 75 years of age inclusive. Female of non-childbearing potential or male. Non-childbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: has undergone radiotherapy within 2 years prior to study entry; has been treated with a dopamine agonist and/or gh receptor antagonist or has undergone pituitary surgery within 3 months prior to study entry; is anticipated to require pituitary surgery or radiotherapy during the study.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Lanreotide study: the participants and staff both knew the treatment.

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

It started in 2015-03 with completion listed for 2017-11-28.

It ran at 36 sites in Italy (6), Russia (6), France (4), Poland (4), Spain (3) and United Kingdom (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PK Analysis of Lanreotide: Maximum Observed Serum Concentration (Cmax). PK Analysis of Lanreotide: Time to Reach Maximum Serum Concentration (Tmax). PK Analysis of Lanreotide: Apparent Terminal Elimination Half-life (t1/2).

It also tracked 9 secondary outcomes, for example Overall Summary of Number of Subjects With AEs, PK Analysis of Glycofurol Excipients: Cmax, PK Analysis of Glycofurol Excipients: Tmax, PD Analysis: Mean Change From Baseline in Insulin-like Growth Factor 1 (IGF-1), PD Analysis: Mean Change From Baseline in Growth Hormone (GH) and PD Analysis: Mean Change From Baseline in Free Triiodothyroxine (FT3) and Free Thyroxine (FT4).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Lanreotide in 28 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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