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Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects

NCT01409122 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2012-11-09

No results posted yet for this study

Summary

This is a four-part study of the safety, tolerability, and PK profile of sodium nitrite inhalation solution (AIR001) of ascending multiple doses (Part A) and of escalating doses with steady-state sildenafil (Part B) to healthy male and female subjects, as well as assessment of the safety and tolerability of multiple doses of AIR001 to patients with pulmonary arterial hypertension (part C) with a single dose PK study of AIR001 utilizing three different nebulizers (Part D).

Conditions

Interventions

DRUG

15 mg sodium nitrite inhalation solution

15 mg sodium nitrite inhalation solution Q8H

DRUG

90 mg sodium nitrite inhalation solution

90 mg sodium nitrite inhalation solution Q8H

DRUG

45 mg sodium nitrite inhalation solution

45 mg sodium nitrite inhalation solution Q8H

DRUG

120 mg sodium nitrite inhalation solution

120 mg sodium nitrite inhalation solution or placebo Q8H

DRUG

25% MTD sodium nitrite inhalation solution

Multiple oral doses of 20 mg sildenafil will be administered open-label Q8H to a single cohort of eight subjects on Days 1 to 6. A single dose of sodium nitrite inhalation solution equal to 25% of the maximum tolerated dose (MTD) identified in Part A (or placebo) will be administered on Day 4, a single dose equal to 50% of the MTD (or placebo) will be administered on Day 5, and a single dose equal to 100% of the MTD (or placebo) will be administered on Day 6.

Sponsors & Collaborators

  • Aires Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Azra Hussaini, MD · PAREXEL International - Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
56 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409122 on ClinicalTrials.gov