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

Pulmonary Arterial Hypertension Clinical Trial

— AIR001-CS02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814645
• Other study ID #: AIR001 CS02
• Status: Completed
• Phase: Phase 1
• First received: December 22, 2008
• Last updated: February 15, 2012
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2012
• Source: Aires Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Sodium Nitrite Inhalation Solution
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
• 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.

Locations

Country	Name	City	State
United States	DaVita Clinical Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Aires Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of pulmonary arterial pressures by echocardiography.		Pretreatment and up to 2 hours post treatment	No
Secondary	Plasma pharmacokinetics		Pretreatment to 8 hours post treatment	No
Secondary	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	Yes