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Intra-Arterial Microdosing: Proof-of-Concept in Humans

NCT02304211 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-12-23

No results posted yet for this study

Summary

The purpose of this protocol is to demonstrate that intra-arterial administration of a drug can generate information in a manner that faithfully mimics effects of systemic administration but with little or no systemic effects.

Conditions

  • Healthy

Interventions

DRUG

Insulin

Insulin will be administered either into the radial artery (microdose intervention) or IV (systemic intervention).

Sponsors & Collaborators

Principal Investigators

  • Robert J. Noveck, M.D., Ph.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02304211 on ClinicalTrials.gov