Healthy Volunteer Study Clinical Trial
Official title:
A Two-Part, Phase 1, Randomized, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intranasal Octreotide (DP1038) Versus Subcutaneous Sandostatin® Injection in Healthy Adult Volunteers
The purpose of the study is to investigate the drug octreotide acetate in a new intranasal formulation and compare it to the FDA-approved subcutaneous (SC) injection formulation. The two octreotide acetate formulations will be evaluated following separate administrations for safety and tolerability including any side effects, the speed at which the drug is absorbed and eliminated in the body, and the ability of the drug to lower the levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).
Octreotide is a synthetic octapeptide analog of naturally occurring somatostatin, with
similar pharmacological effects but a longer duration of action. It inhibits the
pathological secretion of GH from pituitary adenomas, and of serotonin and other hormones by
tumors of the gastroenteropancreatic endocrine system. Currently, only injectable octreotide
and somatostatin analogs have been approved, for the indications of acromegaly, carcinoid
tumors, and vasoactive intestinal peptide tumors.
DP1038, an intranasal formulation of octreotide, is being developed for the treatment of
acromegaly, a rare chronic disorder arising from the overproduction of GH, predominantly by
pituitary adenomas. Excess GH and associated IGF-1 levels are responsible for multiple
symptoms (e.g., headache, tissue swelling, perspiration, joint pain) and significant
comorbidities (e.g., diabetes, sleep apnea, cardiovascular abnormalities such as
hypertension). In most patients with acromegaly, octreotide consistently normalizes GH and
IGF-1 serum concentrations, thereby markedly reducing clinical symptoms.
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