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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
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).
Details
| Lead sponsor | Dauntless Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | 2017-01 |
| Completion | 2017-03 |
Conditions
- Healthy Volunteer Study
Interventions
- Intranasal octreotide acetate
- Subcutaneous octreotide acetate
- Growth hormone-releasing hormone
- Arginine hydrochloride
Primary outcomes
- Percentage of subjects reporting adverse events (AEs)/serious adverse events (SAEs). — Both Study Parts: Entire study duration, an average of 1 week.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE.
Countries
United States