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Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
NCT03031535 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Intranasal octreotide acetate
- DRUG Subcutaneous octreotide acetate
- DIAGNOSTIC_TEST Growth hormone-releasing hormone
- DIAGNOSTIC_TEST Arginine hydrochloride
Study Locations (1)
Arizona
- Celerion, Inc. — Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-01 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03031535
The ClinicalTrials.gov registry entry for NCT03031535 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dauntless Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Healthy Volunteer Study appearing as the primary indexed condition, and to 4 interventions — of which Intranasal octreotide acetate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03031535 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03031535 about?
NCT03031535 is a clinical study titled "Study of Intranasal Octreotide (DP1038) 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 ...
What is the current status of trial NCT03031535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-01. Estimated completion is 2017-03.
What conditions does trial NCT03031535 study?
This clinical trial studies the following conditions: Healthy Volunteer Study. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03031535?
The interventions under investigation include: Intranasal octreotide acetate (DRUG), Subcutaneous octreotide acetate (DRUG), Growth hormone-releasing hormone (DIAGNOSTIC_TEST), Arginine hydrochloride (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03031535?
This trial is sponsored by Dauntless Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03031535 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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