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OpenTrials
Completed

NCT Number: NCT01143051

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Amphastar Location 1

Cypress, California, 90630, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epinephrine inhalation aerosol

Drug

Single dose 220 mcg/inhalation, 10 inhalations

Other names: Primatene Mist

Primary outcomes

  1. Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine

    Time frame: 0 to 30 minutes prior to dosing

    Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.

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

    Time frame: Pre-dose to 6 hours post-dose

    Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC[0-6]) was calculated using the trapezoidal rule.

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

    Time frame: Pre-dose to 6 hours post-dose

    Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.

  4. Time to Reach Peak Concentration (Tmax) for Total Epinephrine

    Time frame: Pre-dose to 6 hours post-dose

    Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.

  5. Half-life (t1/2) for Total Epinephrine

    Time frame: Pre-dose to 6 hours post-dose

    Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.

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

    Time frame: Pre-dose to 6 hours post-dose

    Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.

Secondary outcomes

  1. Vital Signs: Systolic Blood Pressure (SBP)

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.

  2. Vital Signs: Diastolic Blood Pressure (DBP)

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.

  3. Vital Signs: Heart Rate (HR)

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.

  4. ECG: QT Interval

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.

  5. ECG: QTc Interval

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.

  6. Serum Glucose Levels

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.

  7. Serum Potassium Levels

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.

  8. Hand Tremor Scores

    Time frame: Pre-dose (baseline) to 360 minutes post-dose

    Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose.

  9. Number of Subjects With Significant Changes in Physical Examination

    Time frame: Approximately 6 weeks

    Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit.

  10. Number of Subjects With Significant Changes in Laboratory Tests

    Time frame: Approximately 6 weeks

    Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit.

Sponsors and collaborators

Lead sponsor

Amphastar Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 14, 2010
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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