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

NCT01143051 | Completed Phase 1 Results

• 1 other identifier: API-E004-CL-B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Pharmacokinetics; Epinephrine; Bronchodilator; metered dose inhaler

Outcome Measures

Primary Outcomes (6)

• Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine

  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.

  0 to 30 minutes prior to dosing

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

  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.

  Pre-dose to 6 hours post-dose

• Peak Concentration (Cmax) for Total Epinephrine From Time Zero 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.

  Pre-dose to 6 hours post-dose

• Time to Reach Peak Concentration (Tmax) for Total Epinephrine

  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.

  Pre-dose to 6 hours post-dose

• Half-life (t1/2) for Total Epinephrine

  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.

  Pre-dose to 6 hours post-dose

• Concentration vs. Time for Total Epinephrine From Time Zero 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.

  Pre-dose to 6 hours post-dose

Secondary Outcomes (10)

• Vital Signs: Systolic Blood Pressure (SBP)

  Pre-dose (baseline) to 360 minutes post-dose

• Vital Signs: Diastolic Blood Pressure (DBP)

  Pre-dose (baseline) to 360 minutes post-dose

• Vital Signs: Heart Rate (HR)

  Pre-dose (baseline) to 360 minutes post-dose

• ECG: QT Interval

  Pre-dose (baseline) to 360 minutes post-dose

• ECG: QTc Interval

  Pre-dose (baseline) to 360 minutes post-dose

Study Arms (3)

Treatment C

ACTIVE COMPARATOR

Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.

Drug: epinephrine inhalation aerosol

Treatment 1

EXPERIMENTAL

T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation

Drug: epinephrine inhalation aerosol

Treatment 2

EXPERIMENTAL

HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation

Drug: epinephrine inhalation aerosol

Interventions

epinephrine inhalation aerosol DRUG

Single dose 220 mcg/inhalation, 10 inhalations

Also known as: Primatene Mist

Treatment C

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• Other criteria apply.
• 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

Sponsors & Collaborators

• Amphastar Pharmaceuticals, Inc.: lead

Study Sites (1)

Amphastar Location 1

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Stephen A. Campbell, Esq.
• Organization: Amphastar Pharmaceuticals, Inc.

stephenc@amphastar.com

(909) 980-9484

Study Officials

• Medical Director

  Amphastar Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 14, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 25, 2018
• Results First Posted: July 15, 2014

Record last verified: 2018-09

Locations

US (1)