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

This study has been completed.
Sponsor:
Information provided by:
Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01255709
First received: December 3, 2010
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Treatment arm T1
Drug: Treatment arm T2
Drug: Treatment arm C
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: CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pharmacokinetics including maximum concentration and area under the curve [ Time Frame: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose. ] [ Designated as safety issue: No ]

    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:
  • Vital Signs [ Time Frame: within 30 min predose, at 30, 60 and 360 min postdose ] [ Designated as safety issue: Yes ]
    Systolic and Diastolic Blood pressure and heart rate

  • 12-lead Electrocardiogram (ECG) [ Time Frame: within 30 min pre-dose, and at 15 and 120 min post-dose ] [ Designated as safety issue: Yes ]
    12 lead ECG (Routine and QT/QTc intervals)

  • Telemetry ECG [ Time Frame: within 30 min pre-dose, and during the initial 5 min post-dose ] [ Designated as safety issue: Yes ]
    Telemetry recording of heart rate


Enrollment: 24
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm T1
epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
Drug: Treatment arm T1
epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
Other Name: Primatene Mist HFA
Active Comparator: Treatment arm C
epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Drug: Treatment arm C
epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Other Name: Primatene Mist (epinephrine inhalation aerosol, USP)
Experimental: Treatment arm T2
epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
Drug: Treatment arm T2
epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
Other Name: Primatene Mist HFA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255709

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

Publications:
Responsible Party: Medical Director, Amphastar Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01255709     History of Changes
Other Study ID Numbers: API-E004-CL-B3
Study First Received: December 3, 2010
Last Updated: January 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amphastar Pharmaceuticals, Inc.:
Asthma
shortness of breath
wheezing

Additional relevant MeSH terms:
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 02, 2014