Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer Study

In brief

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).

Key facts

Study ID

NCT03031535

Run by

Dauntless Pharmaceuticals

People needed

32

Starts

2017-01-01

Expected to finish

2017-03-01

Last updated by the study team

2017-05-12

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body mass index (BMI) 18 and <28 kg/m2 (to minimize variability in SC absorption).
• Be in good general health.

You may not qualify if…

• 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.

Where it is running

• Celerion, Inc. — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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