Spots Global Cancer Trial Database for A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
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Trial Identification
Brief Title: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Official Title: A Phase 1b Study in Patients With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) to Characterize the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Debio 4126, a 12-week Prolonged-release Octreotide Formulation
Study ID: NCT05364944
Study Description
Brief Summary: This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rigshospitalet, Endokrinologisk afdeling, Copenaghen, , Denmark
CHU Angers, Angers, , France
AP-HP Hopital Bicetre, Le Kremlin-bicetre, , France
AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse, Marseille, , France
Medicover Praxis fur Neuroendokrinologie, Munich, , Germany
Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson Hospita, Petach Tikva, , Israel
Sheba Medical Center, Endocrine institute, Ramat Gan, , Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milano, , Italy
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach, Katowice, , Poland
Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii, Warszawa, , Poland
Hospital de la Santa Creu i Sant Pau Barcelon, Barcelona, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
University Hospital Coventry, WISDEM Centre, UHCW NHS Trust, Coventry, , United Kingdom
Royal Free London NHS Foundation Trust, London, , United Kingdom
Contact Details
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