A First-in-Human Study of a Controlled Release Formulation of Lanreotide acetate in healthy male volunteers

This study will determine the pharmacokinetics and safety of the controlled released formulation of Lanreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-50, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), 8 participants in this study will receive one injection of Lanreotide acetate at a dose of 60mg. In the absence of safety issues, the remaining 8 participants will receive one injection of Lanreotide acetate at a dose of 120mg. As part of the study, participants will undergo safety assessments, Plasma/serum pharmacokinetic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. Compared to the product already available on the market, this new lanreotide formulation [Lanreotide CRF] allows for a more convenient administration for both the patients and caregivers. The Lanreotide CRF is provided in a shorter and standard pre-filled syringe and a smaller needle is used for the injection (21G needle). In terms of PK profile, an equivalent performance is expected for the new Lanreotide CRF formulation when compared to the marketed product. It is hoped this research will determine whether this new lanreotide formulation can be administered safely without causing severe reactions. Once the PK profiles and safety have been determined in healthy volunteers, additional trials investigating the efficacy of Lanreotide CRF as a treatment for patients with neuroendocrine cancer or acromegaly may proceed.