Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers (AIR001-CS02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aires Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00814645
First received: December 22, 2008
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Sodium Nitrite Inhalation Solution
Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Aires Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • The measurement of pulmonary arterial pressures by echocardiography. [ Time Frame: Pretreatment and up to 2 hours post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma pharmacokinetics [ Time Frame: Pretreatment to 8 hours post treatment ] [ Designated as safety issue: No ]
  • Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events. [ Time Frame: Pretreatment, post treatment, and 24 hours post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose level 1
a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization
Drug: Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Other Name: AIR001 Inhalation Solution
Active Comparator: Dose level 2
a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Drug: Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Other Name: AIR001 Inhalation Solution
Active Comparator: Dose level 3
a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Drug: Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Other Name: AIR001 Inhalation Solution
Active Comparator: Dose level 4
a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Drug: Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Other Name: AIR001 Inhalation Solution
Placebo Comparator: 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.
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 Name: AIR001 Inhalation Solution

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814645

Locations
United States, Minnesota
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Aires Pharmaceuticals, Inc.
Investigators
Principal Investigator: Suzanne K Swan, M.D. Davita Clinical Research
  More Information

No publications provided

Responsible Party: Aires Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00814645     History of Changes
Other Study ID Numbers: AIR001 CS02
Study First Received: December 22, 2008
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Hypertension, Pulmonary
Hypertension
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014