Phase 2
Completed N=24
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Source: ClinicalTrials.gov NCT01143051 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine — 9.3; 8.9; 7.8 pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine |
9.3; 8.9; 7.8 | — |
| PRIMARY Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) |
7938; 9438; 7218 | — |
| PRIMARY Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose |
340; 444; 139 | — |
| PRIMARY Time to Reach Peak Concentration (Tmax) for Total Epinephrine |
34.6; 37.0; 38.0 | — |
| PRIMARY Half-life (t1/2) for Total Epinephrine |
125.9; 158.8; 237.3 | — |
| PRIMARY Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose |
9.3; 8.9; 7.8; 339.6; 442.4; 130.2 | — |
| SECONDARY Vital Signs: Systolic Blood Pressure (SBP) |
110; 112; 111; 123; 122; 121 | — |
| SECONDARY Vital Signs: Diastolic Blood Pressure (DBP) |
62; 61; 61; 63; 64; 65 | — |
| SECONDARY Vital Signs: Heart Rate (HR) |
60; 62; 58; 67; 69; 62 | — |
| SECONDARY ECG: QT Interval |
416; 407; 423; 404; 405; 413 | — |
| SECONDARY ECG: QTc Interval |
407; 407; 403; 408; 411; 412 | — |
| SECONDARY Serum Glucose Levels |
83; 83; 84; 101; 105; 96 | — |
| SECONDARY Serum Potassium Levels |
4; 4; 4; 4; 4; 4 | — |
| SECONDARY Hand Tremor Scores |
0.0; 0.0; 0.0; 0.1; 0.2; 0.1 | — |
| SECONDARY Number of Subjects With Significant Changes in Physical Examination |
— | — |
| SECONDARY Number of Subjects With Significant Changes in Laboratory Tests |
— | — |
Eligibility 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;
- 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
Data sourced from ClinicalTrials.gov (NCT01143051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.