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

Phase 1/2 Completed 28 enrolled Ipsen

NaSingle-groupOpen-labelTreatment

Summary

The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

Timeline

Start: 2015-03
Primary completion: 2017-11-28
Completion: 2017-11-28

Publications

Neggers S, Badiu C, Biagetti B, Durand-Gasselin L, Petit A, Petrossians P, Regnault B, Rich D, Shafigullina Z, Shustov S, Vydrych A. Pharmacological and safety profile of a prolonged-release lanreotide formulation in acromegaly. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1551-1560. doi: 10.1080/17512433.2021.1986004. Epub 2021 Nov 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lanreotide	Other / unclassified	180 mg	Subcutaneous
Subject	Lanreotide	Other / unclassified	270 mg	Subcutaneous
Subject	Lanreotide	Other / unclassified	360 mg	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications