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

NCT00814645 | Completed Phase 1

• 1 other identifier: AIR001 CS02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• The measurement of pulmonary arterial pressures by echocardiography.

  Pretreatment and up to 2 hours post treatment

Secondary Outcomes (2)

• 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

Study Arms (5)

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

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

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

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

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)

Interventions

Sodium Nitrite Inhalation Solution DRUG

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

Also known as: AIR001 Inhalation Solution

Dose level 1; Dose level 2; Dose level 3; Dose level 4

Placebo and AIR001 Inhalation Solution (Expansion arm) DRUG

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.

Also known as: AIR001 Inhalation Solution

Expansion arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aires Pharmaceuticals, Inc.: lead

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Suzanne K Swan, M.D.

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 25, 2008
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

US (1)