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Completed

NCT Number: NCT00814645

Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite 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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Nitrite Inhalation Solution

Drug

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

Other names: AIR001 Inhalation Solution

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.

Other names: AIR001 Inhalation Solution

Primary outcomes

  1. The measurement of pulmonary arterial pressures by echocardiography.

    Time frame: Pretreatment and up to 2 hours post treatment

Secondary outcomes

  1. Plasma pharmacokinetics

    Time frame: Pretreatment to 8 hours post treatment

  2. 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

Sponsors and collaborators

Lead sponsor

Aires Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: AIR001-CS02

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 25, 2008
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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