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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: Completed Phase 1 study of Healthy Volunteer Study, sponsored by Dauntless Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
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 |
What the finished NCT03031535 record still lists
NCT03031535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, roughly in line with the 33-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target.
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03031535's enrollment target sits among peer trials
32 4th of 9 higher than 6 of 9 other Healthy Volunteer Study trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer Study trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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