Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

Condition(s) targeted: Asthma

Intervention: epinephrine inhalation aerosol (Drug); epinephrine inhalation aerosol (Drug); epinephrine inhalation aerosol (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Amphastar Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Amphastar Pharmaceuticals, Inc.

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.

Official title: Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine

Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])

Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose

Time to Reach Peak Concentration (Tmax) for Total Epinephrine

Half-life (t1/2) for Total Epinephrine

Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose

Secondary outcome:

Vital Sign Analysis

Telemetry and 12 Lead ECG Analysis

Blood Values

Hand Tremor

General Health Assessment

Laboratory Analysis

Detailed description: This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in ~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

- At the Screening Visit and the beginning of each Study Visit, each subject will be

trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits:

- Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation),

totaling 1. 25 mg of epinephrine;

- Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation),

totaling 1. 60 mg of epinephrine;

- Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation,

totaling 2. 2 mg of epinephrine base equivalent).

- PK blood samples will be taken from a vein at scheduled time points.

- Safety parameters and adverse drug events, if any, will be monitored and documented at

each study visit. An End-of-Study (EOS) safety evaluation will be conducted.

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Generally healthy, male and female adults, 18-30 yrs of age at Screening;

- Having no clinically significant respiratory, cardiovascular and other systemic or

organic illnesses, per investigator discretion;

- Women of child-bearing potential must be non-pregnant, non-lactating, and practicing

a clinically acceptable form of birth control;

- Having properly consented and satisfied all other inclusion/exclusion criteria as

required for this protocol.

- Other criteria apply.

Exclusion Criteria:

- A recent or significant smoking history;

- Use of prohibited drugs or failure to observe the drug washout restrictions;

- Having been on other investigational drug/device studies in the last 30 days prior to

Screening.

- Other criteria apply

Amphastar Location 1, Cypress, California 90630, United States

Starting date: January 2010
Last updated: June 13, 2014