drugset / Trial / NCT03031535

Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

NCT03031535

Phase 1 Completed 32 enrolled Dauntless Pharmaceuticals
RandomizedCrossoverQuadruple-blindTreatment

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).

Timeline

Start
2017-01
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Octreotide Peptide 100 ug Intranasal
Subject Octreotide Peptide 400 ug Intranasal
Subject Octreotide Peptide 1200 ug Intranasal
Subject Octreotide Peptide 2000 ug Intranasal

Indications

No indication recorded.