P1, N=27, Not yet recruiting, Michael Gunn | Trial completion date: Dec 2022 --> Mar 2024 | Initiation date: Dec 2021 --> Mar 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
almost 3 years ago
Trial completion date • Trial initiation date • Trial primary completion date
All subjects received Sandostatin® (100μg immediate release; SIR) by deep SC injection 24h before MTD201... MTD201 (30mg) by either IM or SC injection produced continuous octreotide release over a period of at least 63 days at levels predicted to maintain efficacious plasma concentrations at steady state with a dosing interval of up to 8 weeks. Reduced plasma IGF-1 concentrations were maintained throughout the study period. Unlike marketed octreotide depot products, MTD201 can be simply and rapidly reconstituted in WFI to give a stable suspension injectable via 21G needle in a 1.5mL volume.
MTD201 (30mg) by either IM or SC injection produced continuous octreotide release over a period of at least 63 days at levels predicted to maintain efficacious plasma concentrations at steady state with a dosing interval of up to 8 weeks. Reduced plasma IGF-1 concentrations were maintained throughout the study period. Unlike marketed octreotide depot products, MTD201 can be simply and rapidly reconstituted in WFI to give a stable suspension injectable via 21G needle in a 1.5mL volume.