Status:
COMPLETED
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
Lead Sponsor:
Aires Pharmaceuticals, Inc.
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 reducti...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00814645
Start Date
December 1 2008
End Date
June 1 2009
Last Update
February 17 2012
Active Locations (1)
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1
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404