L-NMMA Dose-response Study in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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Isotonic saline infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Isotonic saline solution IV priming dose + IV infusion for 1 hour

Intravenous L-NMMA dose 2

Group Type ACTIVE_COMPARATOR

NG-monomethyl-L-arginine (L-NMMA)

Intervention Type DRUG

4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour

Intravenous L-NMMA dose 3

Group Type ACTIVE_COMPARATOR

NG-monomethyl-L-arginine (L-NMMA)

Intervention Type DRUG

6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour

Intravenous L-NMMA dose 1

Group Type ACTIVE_COMPARATOR

NG-monomethyl-L-arginine (L-NMMA)

Intervention Type DRUG

3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour

Interventions

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NG-monomethyl-L-arginine (L-NMMA)

3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour

Intervention Type DRUG

NG-monomethyl-L-arginine (L-NMMA)

6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour

Intervention Type DRUG

NG-monomethyl-L-arginine (L-NMMA)

4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour

Intervention Type DRUG

Placebo

Isotonic saline solution IV priming dose + IV infusion for 1 hour

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males
* Age 18-35 years
* BMI 18.5-30.0

Exclusion Criteria

* Tobacco or illicit drug use
* Current use of any prescription or non-prescription drugs
* Alcohol abuse
* History of heart failure, lever failure, chronic kidney disease or cerebral insult
* Diabetes
* Clinical or paraclinical signs of infection
* Pathologic ECG
* Ambulatory blood pressure \>140/90 mmHg
* Abnormal blood or urin screening tests

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes