Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension

In brief

This study is designed to investigate the safety and tolerability of AIR001 Inhalation Solution when administered under conditions of hypoxia and to identify dose levels of drug resulting in a reduction in pulmonary arterial pressure under these hypoxic conditions.

Key facts

Study ID

NCT00814645

Run by

Aires Pharmaceuticals, Inc.

People needed

25

Starts

2008-12-01

Expected to finish

2009-06-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal male and female volunteers
• Age 18-55
• Demonstrate a rise in pulmonary artery pressure to low inspired oxygen concentration (a normal response to breathing a low level of oxygen)

You may not qualify if…

• Significant medical illnesses
• Risk factors for pulmonary hypertension
• G6PD or Cytochrome B5 Reductase deficiencies
• History of any form of altitude sickness
• Current prescription or over the counter medication use

Where it is running

• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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