Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-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. The current study is designed to complement an earlier PK study, API-E004-CL-B, for a more thorough evaluation of the E004 PK. Safety of E004 will also be evaluated.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amphastar Pharmaceuticals, Inc.
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

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;

• Body weight greater than or equal to 50 kg for men and greater than or equal to 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive

• Sitting blood pressure less than or equal to 135/90 mmHg;

• Demonstrating negative alcohol/drug screen tests;

• Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;

• 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.

Exclusion Criteria:

• A smoking history of more than or equal to 10 pack-years, or having smoked within 6 months prior to Screening;

• Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening

• Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including but not limited to: asthma, COPD, cystic fibrosis, bronchiectasis, tuberculosis, emphysema, etc.

• Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study

• Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e., epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid)

• Use of prohibited drugs or failure to observe the drug washout restrictions

• Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening.