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Study of Intranasal Octreotide (DP1038) in Healthy Adult Volunteers

NCT03031535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-05-12

No results posted yet for this 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

  • Healthy Volunteer Study

Interventions

DRUG

Intranasal octreotide acetate

Intranasal spray of octreotide acetate

DRUG

Subcutaneous octreotide acetate

Subcutaneous injectable solution of octreotide acetate

DIAGNOSTIC_TEST

Growth hormone-releasing hormone

Part of the well established GHRH/Arginine challenge to detect GH deficiency.

DIAGNOSTIC_TEST

Arginine hydrochloride

Part of the well established GHRH/Arginine challenge to detect GH deficiency.

Sponsors & Collaborators

  • Dauntless Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jeffrey Zacher, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031535 on ClinicalTrials.gov