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

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

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 Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Sodium Nitrite Inhalation Solution; Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • DaVita Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: AIR001 Inhalation Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The measurement of pulmonary arterial pressures by echocardiography.	Pretreatment and up to 2 hours post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma pharmacokinetics	Pretreatment to 8 hours post treatment
Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events.	Pretreatment, post treatment, and 24 hours post treatment

Collaborators and Investigators

• Sponsor: Aires Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Suzanne K Swan, M.D., DaVita Clinical Research

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: December 24, 2008
• First Posted (Estimate): December 25, 2008

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Pharmaceutical Solutions
• Other Study ID Numbers: AIR001 CS02