Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

Phase 2

Completed

• Conditions: Asthma

• Registration Number: NCT01255709
• Lead Sponsor: Amphastar Pharmaceuticals, Inc.

Brief Summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers.

Detailed Description

The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2016-02
• Disposition First Submitted: 2016-02-18
• Disposition First Submitted QC: 2016-02-18
• Last Update Submitted: 2016-02-18
• Disposition First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Generally healthy at screening;
• Body weight ≥ 50 kg for men and ≥ 45 kg for women;
• Sitting blood pressure ≤ 135/90 mmHg;
• Demonstrating negative hIV, HBsAG and DCV-Ab screen tests;
• Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
• Properly consented
• Other criteria apply

Exclusion Criteria

• A smoking history of ≥10 pack-years, or having smoked within 6 months prior to Screening;
• Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
• Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
• Known intolerance or hypersensitivity to the study MDI ingredients;
• Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening;
• Other criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics including maximum concentration and area under the curve	-30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.	Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3.; * Mean Maximum concentration of epinephrine (Cmax for epinephrine); * Mean Area Under the Curve (AUC) for epinephrine; * Time to maximum concentration (tmax) and Half life of the drug (t1/2); * Epinephrine concentrations versus time

Secondary Outcome Measures

Name	Time	Method
Vital Signs	within 30 min predose, at 30, 60 and 360 min postdose	Systolic and Diastolic Blood pressure and heart rate
12-lead Electrocardiogram (ECG)	within 30 min pre-dose, and at 15 and 120 min post-dose	12 lead ECG (Routine and QT/QTc intervals)
Telemetry ECG	within 30 min pre-dose, and during the initial 5 min post-dose	Telemetry recording of heart rate

Trial Locations

Locations (1)

Amphastar Study Site 1; 🇺🇸 Cypress, California, United States