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Clinical Trials/NCT00179010
NCT00179010TerminatedPhase 1

Use of AMP to Improve Tissue Delivery of Adenosine

Vanderbilt University Medical Center1 site in 1 country13 target enrollmentStarted: October 2003Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
13
Locations
1
Primary Endpoint
Interstitial Adenosine Levels

Study Overview

Brief Summary

Adenosine and AMP are substances normally present in the body. Adenosine is also given for the treatment of some heart rhythm problems and may be used to reduce heart damage during heart attacks. The problem in using adenosine is that it is taken up by cells and, therefore, very little of the adenosine we give by vein or in the artery actually reaches the tissue. We propose to use AMP as a way to improve delivery of adenosine. AMP is inactive by itself, but is converted to adenosine in tissue. We hope that by giving AMP we will increase levels of adenosine in tissue. To see if this is true, we will give either adenosine or AMP into the forearm artery while we measure how much adenosine reaches the forearm tissue.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy volunteers
  • Age 18-65
  • Non smokers

Exclusion Criteria

  • Any chronic disease

Arms & Interventions

Adenosine then Adenosine Mono Phosphate (AMP)

Experimental

Intrarterial infusion of adenosine then same subject switch to AMP one month apart.

Intervention: Adenosine (Drug)

Adenosine then Adenosine Mono Phosphate (AMP)

Experimental

Intrarterial infusion of adenosine then same subject switch to AMP one month apart.

Intervention: Adenosine Mono Phosphate (AMP) (Drug)

Adenosine Mono Phosphate (AMP) then adenosine

Experimental

Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.

Intervention: Adenosine (Drug)

Adenosine Mono Phosphate (AMP) then adenosine

Experimental

Intrarterial infusion of AMP then same subject switch to Adenosine one month apart.

Intervention: Adenosine Mono Phosphate (AMP) (Drug)

Outcomes

Primary Outcomes

Interstitial Adenosine Levels

Time Frame: Microdyalysis samples for adenosine, were collected for 15 minutes at each stage of the study (baseline and each dose of adenosine or AMP)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Italo Biaggioni

Professor of Medicine

Vanderbilt University Medical Center

Study Sites (1)

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