Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
NCT ID: NCT00814645
Last Updated: 2012-02-17
Study Results
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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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2008-12-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose level 1
a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization
Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Dose level 2
a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Dose level 3
a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Dose level 4
a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Expansion arm
On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
Placebo and AIR001 Inhalation Solution (Expansion arm)
On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
Interventions
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Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Placebo and AIR001 Inhalation Solution (Expansion arm)
On Day 1, subjects will receive a single placebo-form dose of inhaled nebulized AIR001 Inhalation Solution (containing diluent and excipient solutions alone). On Day 2, the same subjects will receive a single administration of AIR001 Inhalation Solution at the minimum pharmacologically active and safe dose identified from dose levels 1-4. Subjects will be blinded to the treatment schema.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Aires Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Suzanne K Swan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Davita Clinical Research
Locations
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DaVita Clinical Research
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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AIR001 CS02
Identifier Type: -
Identifier Source: org_study_id
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