Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
Study of Intranasal Octreotide (DP1038) 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.
Key eligibility criteria:

 Inclusion Criteria:

 -  Body mass index (BMI) 18 and <28 kg/m2 (to minimize variability in SC absorption).

 -  Be in good general health.

 Exclusion Criteria:

 -  Use of any tobacco product within 30 days prior to first dose of study drug.

 -  Use of any prescription or non-prescription drugs or dietary supplements within 7
 days, insulin or hypoglycemic drugs within 3 months, estrogen-containing medication
 within 3 months, or drugs that may affect GH and IGF-1 levels (e.g., alpha-adrenergic,
 beta-adrenergic, and cholinergic drugs) within 1 month prior to dosing.

 -  Subjects will also be excluded if they have a history of gallbladder disease,
 hypothyroidism, or unexplained hypoglycemia.