drugset / Trial / NCT03031535
Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.