L-NMMA Dose-response Study in Healthy Subjects

Regional Hospital Holstebro

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: NG-monomethyl-L-arginine (L-NMMA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01070940

EBP.FHC.1.2009

2009-017001-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12 participants in 4 patient groups, including a placebo group

Isotonic saline infusion

Placebo Comparator group

Treatment:

Drug: Placebo

Intravenous L-NMMA dose 2

Active Comparator group

Treatment:

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

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

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

Intravenous L-NMMA dose 3

Active Comparator group

Treatment:

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

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

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

Intravenous L-NMMA dose 1

Active Comparator group

Treatment:

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

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

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