Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dauntless Pharmaceuticals
• Treatments: Growth Hormone-Releasing Hormone; Hormones; Octreotide

Criteria

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.