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

Phase 1

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Sodium Nitrite Inhalation Solution; Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)

• Registration Number: NCT00814645
• Lead Sponsor: Aires Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-24
• Study First Posted: 2008-12-25
• Primary Completion: 2009-04
• Study Completion: 2009-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 2	Sodium Nitrite Inhalation Solution	a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Dose level 3	Sodium Nitrite Inhalation Solution	a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Dose level 4	Sodium Nitrite Inhalation Solution	a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Dose level 1	Sodium Nitrite Inhalation Solution	a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization
Expansion arm	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.

Primary Outcome Measures

Name	Time	Method
The measurement of pulmonary arterial pressures by echocardiography.	Pretreatment and up to 2 hours post treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

DaVita Clinical Research; 🇺🇸 Minneapolis, Minnesota, United States