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

Sponsored by:	Aires Pharmaceuticals, Inc.
Information provided by:	Aires Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00814645

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 I

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Dietary Sodium High Blood Pressure

Drug Information available for: Sodium nitrite

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacodynamics Study
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

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 ]

Estimated Enrollment:	25
Study Start Date:	December 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dose level 1: Active Comparator 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
Dose level 2: Active Comparator 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
Dose level 3: Active Comparator 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
Dose level 4: Active Comparator 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
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.	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.

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

Contacts

Contact: Colleen Herbranson

612-852-7002

Colleen.Herbranson@davita.com

Locations

United States, Minnesota
DaVita Clinical Research	Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Colleen Herbranson 612-852-7002 Colleen.Herbranson@davita.com
Principal Investigator: Suzanne K Swan, M.D.

Sponsors and Collaborators

Aires Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Suzanne K Swan, M.D.

DaVita Clinical Research

More Information

Responsible Party:	Aires Pharmaceuticals, Inc. ( Gary T. Elliott )
Study ID Numbers:	AIR001 CS02
Study First Received:	December 22, 2008
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00814645
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Signs and Symptoms
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Healthy
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009