NCT01409122 - Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions

Pulmonary HypertensionPulmonary Arterial Hypertension

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.

Trial Locations (1)

21225

PAREXEL International Early Phase Clinical Unit - Baltimore, Baltimore