Phase 1 Pharmacokinetic and Pharmacodynamic Study of APOC, a New Controlled Release Formulation (CRF) of 15mg Octreotide Acetate in Healthy Male Volunteers

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Introduction: Somatostatin analogues (SSAs) are considered the gold standard for systemic therapy of advanced neuroendocrine tumors (NETs). Octreotide is one of the SSAs most widely used in long-term therapies of NETs. There is increasing evidence that clinical benefits could be obtained with higher SSAs circulating levels but remain unreachable with current products without impacting significantly the quality of life of the patients. APOC is a new injectable controlled release technology containing Octreotide invented and developed by Ascil-Biopharm and designed to cover specifically these clinical unmet needs. It is presented as ready-to-use and can easily be manufactured at selected doses and durations in prefilled syringe.

Aim(s): -

Materials and methods: The Phase 1 study was designed to evaluate the safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an APOC CRF form of Octreotide Acetate in healthy male subjects. A single center, single blinded, parallel study will be performed. 4 cohorts of 8 volunteers will participate in the study, distributed in 4 groups. APOC (15mg, single dose and repeated dose) will be administrated via IM and SC after a Single Dose Formulation of reference medication (100µg), that will be applied in order to ensure that no hypersensitivity reactions will occur when CRF will be administrated. PK and PD determinations will be performed and local tolerance assessed for the CRF until the end of the study.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author:

Authors: Antonijoan Arbós R, Lachamp L, Cabello F, Molina P, Coimbra J,

Keywords: Apoc, somatostatin, analogues, controlled release, octreotide, octreotide acetate, phase 1, studies, clinical trial, study, neuroendocrine, tumor, slow, release, formulation, therapeutics, injection, drug effect, clinical, trial, im, sc,