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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Intramuscular (IM) injection
Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration
Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration
Rigshospitalet, Endokrinologisk afdeling
Copenhagen, Denmark
CHU Angers
Angers, France
Plasma Concentration of Debio 4126 in Acromegaly and GEP-NET Participants
The PK of Debio 4126 will be evaluated in plasma.
Time frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
Assessment of Ratio of Accumulation (Rac) of Octreotide in Plasma After Repeated Administration of Debio 4126 in Acromegaly and GEP-NET Participants
Time frame: Predose at Days -28 to -7; Postdose at multiple timepoints from Day 1 to Day 337
Safety and Tolerability of Debio 4126 as Assessed by Number of Participants With At Least one Treatment Emergent Adverse Events (TEAE) in Acromegaly and GEP-NET Participants
Time frame: Up to Week 65
Local Tolerability of Debio 4126 as Assessed by Pain at Injection Site Based on Pain Visual Analog Scale (VAS) Score in Acromegaly and GEP-NET Participants
Pain VAS scale score will be assessed on 4-point rating scale, where 0=absent and 3=severe.
Time frame: Up to Week 65
Insulin-Like Growth Factor 1 (IGF-1) and Growth Hormone (GH) Levels in Acromegaly Participants
The blood samples will be collected to assess changes in the levels of IGF-1 (in µg/L) and GH (in µg/L).
Time frame: Baseline up to Week 48
Number of Participants With Carcinoid Syndrome Symptoms and use of Rescue Medication for Symptom Control in GEP-NET Participants
Time frame: Baseline up to Week 48
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AP-HP Hopital Bicetre
Le Kremlin-Bicêtre, 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
Petah Tikva, Israel
Sheba Medical Center, Endocrine institute
Ramat Gan, Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 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
Warsaw, Poland
...and 4 more locations