NCT03031535

Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dauntless Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Intranasal octreotide acetate	Intranasal spray of octreotide acetate
DRUG	Subcutaneous octreotide acetate	Subcutaneous injectable solution of octreotide acetate
DIAGNOSTIC_TEST	Growth hormone-releasing hormone	Part of the well established GHRH/Arginine challenge to detect GH deficiency.
DIAGNOSTIC_TEST	Arginine hydrochloride	Part of the well established GHRH/Arginine challenge to detect GH deficiency.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-01-25
• Last updated: 2017-05-12

Locations

1 site across 1 country: United States