Trial | NCT00814645  Report issue

Title

Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sodium nitrite ...

  • Study Participants

    25
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.
Study Started
Dec 31
2008
Primary Completion
Apr 30
2009
Study Completion
Jun 30
2009
Last Update
Feb 17
2012
Estimate

Drug Sodium Nitrite Inhalation Solution

a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization

  • Other names: AIR001 Inhalation Solution

Drug 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 names: AIR001 Inhalation Solution

Dose level 1 Active Comparator

a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization

Dose level 2 Active Comparator

a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

Dose level 3 Active Comparator

a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

Dose level 4 Active Comparator

a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

Expansion arm Placebo Comparator

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.

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted