Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
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).