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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01143051
First received: June 7, 2010
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: epinephrine inhalation aerosol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by Amphastar Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 5, 15, 30, 45, 60 90, 120, 180, 240 and 360 min postdose ] [ Designated as safety issue: No ]
    PK blood samples will be taken from a vein in a hand or arm via indwelling anticoagulated IV catheters, or by venipunctures, at scheduled time points


Secondary Outcome Measures:
  • Vital Signs [ Time Frame: at baseline, and at 10, 30, 60, 120, 180, and 360 min post-dose. ] [ Designated as safety issue: Yes ]
    Vital signs, i.e., blood pressure (SBP/DBP) and heart rate (HR);

  • Telemetry and 12 lead ECG Analysis [ Time Frame: within 30 min pre-dose, telemetry for 5 min post dose, 12 lead at 30, 90, and 360 min post-dose. ] [ Designated as safety issue: Yes ]

    Telemetry ECG recording of heart rate pre-dose, and during the initial 5 min post-dose.

    A 12-lead ECG (Routine and QT / QTc intervals)at specified intervals


  • Blood Values [ Time Frame: at baseline, and at 15, 30, 60, 120, and 360 min post-dose ] [ Designated as safety issue: Yes ]
    Serum glucose and potassium levels;

  • Hand Tremor [ Time Frame: at baseline, and at 10, 60, and 360 post-dose ] [ Designated as safety issue: Yes ]
    Hand tremor scores

  • General health assessment [ Time Frame: Screening and at or within 7 days after study visit 3 ] [ Designated as safety issue: Yes ]
    Physical examinations

  • Laboratory Analysis [ Time Frame: Screening, after each treatment and end of study, within 7 days of study visit 3 ] [ Designated as safety issue: Yes ]
    Lab tests, including CBC, serum comprehensive metabolic panel, and urinalysis for all subjects, and urinary pregnancy test for women of child-bearing potential.


Enrollment: 22
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment C
Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.
Drug: epinephrine inhalation aerosol
Single dose 220 mcg/inhalation, 10 inhalations
Other Name: Primatene Mist
Experimental: Treatment 1
T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation
Drug: epinephrine inhalation aerosol
HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations
Other Name: Primatene Mist
Experimental: Treatment 2
HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation
Drug: epinephrine inhalation aerosol
HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations
Other Name: Primatene Mist

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.
  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143051

Locations
United States, California
Amphastar Location 1
Cypress, California, United States, 90630
Sponsors and Collaborators
Amphastar Pharmaceuticals, Inc.
Investigators
Study Director: Medical Director Amphastar Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01143051     History of Changes
Other Study ID Numbers: API-E004-CL-B
Study First Received: June 7, 2010
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amphastar Pharmaceuticals, Inc.:
Asthma
Pharmacokinetics
Epinephrine
Bronchodilator
metered dose inhaler

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014