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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sodium Nitrite Inhalation Solution
Placebo and AIR001 Inhalation Solution (Expansion arm)
Sponsored by
Aires Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • DaVita Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dose level 1

Dose level 2

Dose level 3

Dose level 4

Expansion arm

Arm Description

a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization

a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization

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.

Outcomes

Primary Outcome Measures

The measurement of pulmonary arterial pressures by echocardiography.

Secondary Outcome Measures

Plasma pharmacokinetics
Hematology, blood chemistry, coagulation and urinalysis, methemoglobin, oxygen saturation, electrocardiogram, troponin, and vital signs and adverse events.

Full Information

First Posted
December 22, 2008
Last Updated
February 15, 2012
Sponsor
Aires Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00814645
Brief Title
Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aires Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose level 1
Arm Type
Active Comparator
Arm Description
a single dose (5 mg sodium nitrite)of AIR001 Inhalation Solution administered by inhalation following nebulization
Arm Title
Dose level 2
Arm Type
Active Comparator
Arm Description
a single dose(15 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Arm Title
Dose level 3
Arm Type
Active Comparator
Arm Description
a single dose(45 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Arm Title
Dose level 4
Arm Type
Active Comparator
Arm Description
a single dose(113 mg sodium nitrite) of AIR001 Inhalation Solution administered by inhalation following nebulization
Arm Title
Expansion arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium Nitrite Inhalation Solution
Other Intervention Name(s)
AIR001 Inhalation Solution
Intervention Description
a single dose of AIR001 Inhalation Solution administered by inhalation following nebulization
Intervention Type
Drug
Intervention Name(s)
Placebo and AIR001 Inhalation Solution (Expansion arm)
Other Intervention Name(s)
AIR001 Inhalation Solution
Intervention Description
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 Measure Information:
Title
The measurement of pulmonary arterial pressures by echocardiography.
Time Frame
Pretreatment and up to 2 hours post treatment
Secondary Outcome Measure Information:
Title
Plasma pharmacokinetics
Time Frame
Pretreatment to 8 hours post treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne K Swan, M.D.
Organizational Affiliation
Davita Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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