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NCT03031535 · ClinicalTrials.gov registry record · Phase 1
Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers
A Phase 1 study of Healthy Volunteer Study, sponsored by Dauntless Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03031535 is a Phase 1 study of Healthy Volunteer Study that has completed, run by Dauntless Pharmaceuticals. The registered enrollment target is 32 participants, roughly in line with the 33-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT03031535, a Phase 1 study of Healthy Volunteer Study, has completed, sponsored by Dauntless Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 33-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target. The listed sponsor is Dauntless Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT03031535 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
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.
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).
Who is sponsoring clinical trial NCT03031535?
This trial is sponsored by Dauntless Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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Related
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