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

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Asthma

Treatments: Drug: epinephrine inhalation aerosol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01143051

API-E004-CL-B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Treatment C

Active Comparator group

Description:

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

Treatment:

Drug: epinephrine inhalation aerosol

Drug: epinephrine inhalation aerosol

Drug: epinephrine inhalation aerosol

Treatment 1

Experimental group

Description:

T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation

Treatment:

Drug: epinephrine inhalation aerosol

Drug: epinephrine inhalation aerosol

Drug: epinephrine inhalation aerosol

Treatment 2

Experimental group

Description:

HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation

Treatment:

Drug: epinephrine inhalation aerosol

Drug: epinephrine inhalation aerosol

Drug: epinephrine inhalation aerosol