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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05152901
Registration number
NCT05152901
Ethics application status
Date submitted
9/11/2021
Date registered
10/12/2021
Date last updated
24/07/2023
Titles & IDs
Public title
Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
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Scientific title
A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
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Secondary ID [1]
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CTP-00070-00
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaphylactic Reaction
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Condition category
Condition code
Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - EpiPen ®.
Treatment: Drugs - Epinephrine (0.3mg) inhaled
Treatment: Drugs - Epinephrine (1.3mg)
Treatment: Drugs - Epinephrine (4mg)
Active Comparator: EpiPen ®. - Dosage Form- Intra muscularly (IM), Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via IM on day, Visit 2.
Experimental: Epinephrine (0.3mg) - Dosage Form- Inhaled, Dosage- 0.3mg, Dosage Frequency and Duration- Single dose of 0.3mg epinephrine via inhalation on day 2 of Visit 2.
Experimental: Epinephrine (1.3mg) - Dosage Form- Inhaled, Dosage- 1.3mg, Dosage Frequency and Duration- Single dose of 1.3mg epinephrine via inhalation on Visit 3.
Experimental: Epinephrine (4mg) - Dosage Form- Inhaled, Dosage-4mg, Dosage Frequency and Duration- Single dose of 4mg epinephrine via inhalation on Visit 4.
Treatment: Drugs: EpiPen ®.
A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.
Treatment: Drugs: Epinephrine (0.3mg) inhaled
Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2
Treatment: Drugs: Epinephrine (1.3mg)
A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.
Treatment: Drugs: Epinephrine (4mg)
A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with treatment-related adverse events as assessed by Regulatory Activities (MedDRA) Version 22.0 or higher.
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Assessment method [1]
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Timepoint [1]
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Screening through to follow up so approx. 66 days
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Primary outcome [2]
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Safety and tolerability of inhaled epinephrine in healthy participants measured through percentage of subjects with abnormal and clinically significant abnormal hematology values.
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Assessment method [2]
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Timepoint [2]
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Screening through to follow up so approx. 66 days
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Primary outcome [3]
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Safety and tolerability of inhaled epinephrine in healthy participants measured through PR interval in ECG Assessment.
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Assessment method [3]
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PR interval is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization)
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Timepoint [3]
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Screening through to follow up so approx. 66 days
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Primary outcome [4]
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Change in Baseline of heart rate will be monitored from 15 minutes prior to each dosing (to establish baseline) through safety continuous cardiac monitoring (Telemetry) at timepoints to match the pharmacokinetic blood draws.
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Assessment method [4]
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Timepoint [4]
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Screening through to follow up so approx. 66 days
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Primary outcome [5]
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Safety and tolerability of inhaled epinephrine in healthy participants measured through Functional Vital Capacity (FVC) in the Lung Function test assessment.
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Assessment method [5]
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Timepoint [5]
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Screening through to follow up so approx. 66 days
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Secondary outcome [1]
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To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through time to maximum observed epinephrine concentration (Tmax).
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Assessment method [1]
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Timepoint [1]
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Day 1, Day 2, Day16 and Day 30
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Secondary outcome [2]
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To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants by plasma concentration-time profiles (Cmax).
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Assessment method [2]
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Timepoint [2]
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Day 1, Day 2, Day16 and Day 30
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Secondary outcome [3]
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To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through Area under curve (AUC0-t).
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Assessment method [3]
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Area under the drug concentration-time curve, from time zero (time of dosing) to the last time point (AUC0-t)
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Timepoint [3]
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Day 1, Day 2, Day16 and Day 30
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Secondary outcome [4]
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To determine the comparative plasma bioavailability of inhaled epinephrine to intramuscular (IM)epinephrine in healthy participants.
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Assessment method [4]
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Timepoint [4]
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Day 1, Day 2, Day16 and Day 30
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Eligibility
Key inclusion criteria
1. Male or female and = 18 to = 45 years of age at time of signing the Informed Consent
Form.
2. BMI is between =18.00 to 29.00 kg/m2 with a minimum body weight of 45.0 kg.
3. Participant who is in good health based on the results of medical history, physical
examination, vital sign measurements, and clinical laboratory evaluations, as assessed
by the Investigator (or designee) with a resting heart rate of = 90 beats per minute
and systolic blood pressure of = 130/90 mmHg and diastolic blood pressure of = 90/50
mmHg.
4. Has normal lung function assessed using spirometry and defined by FVC = lower limit of
normal (LLN), FEV1/FVC = LLN, and PIF = LLN. (FVC- Functional Vital Capacity; FEV-
Forced Expiratory Volume)
5. Has no history of anaphylaxis or severe allergy requiring the use of epinephrine.
6. Who is a non-smoker; or social smoker who only used nicotine on = 5 occasions within
30 days prior to Screening, a negative cotinine test at Screening, and ability and
willingness to refrain from tobacco products for the duration of the study (from 7
days prior to the first dose through to EOS [Visit 5]).
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Participant who is pregnant or lactating at Screening or planning to become pregnant
(self or partner) at any time during the study (through Visit 5/EOS).
2. Participant has a history of significant hypersensitivity or intolerance to lactose.
3. Participant has a history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, haematological, pulmonary, cardiovascular,
gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as
determined by the Investigator (or designee) except for fully resolved childhood
asthma.
4. Participant has a positive urine drug screen (including cotinine) at Screening and at
Baseline (Visit 2/Day -1).
5. Participant has a positive COVID-19 test at Screening and prior to Baseline (Visit
2/Day -1)
6. Participant took part a clinical study involving administration of an investigational
drug (new chemical entity) in the past 30 days or 5 half-lives prior to Baseline
(Visit 2/Day -1).
7. Participant used or intends to use any prescription or non-prescription
medications/products within 14 days prior to dosing through to Follow-up (Visit 5),
with the exception of Oral contraceptive pill (OCPs) and paracetamol/acetaminophen (1
therapeutic dose [1g] three times per week) at the discretion of the Investigator, and
contraceptives.
8. Participant has a history of alcoholism, substance or drug abuse-related disorders
deemed significant by the Investigator (or designee) (ie, > 14 drinks/week for women
or > 21 drinks/week for men [1 drink = 150 mL of wine or 360 mL of beer or 45 mL of
hard liquor]) within the last 3 months prior to dosing, must not have consumed more
than 14 drinks per week in any week or have a history of alcohol abuse within the last
12 months.
9. Participant has a positive alcohol breath test at Screening and prior to dosing with
Investigational Product (IP) at Visit 2, Visit 3, and Visit 4.
10. Female participant has a positive urine pregnancy test prior to dosing with IP at
Visit 2, Visit, 3, and Visit 4.
11. Participant has a positive test for HIV, hepatitis B surface antigen (HBsAg), or
hepatitis C virus antibody (anti-HCV) with HCV RNA detected at Screening or Day 1 and
hepatitis B core antibody (HBcAb) at Screening only.
12. Participant has presence of any physical or psychological medical condition that, in
the opinion of the Investigator, would make it unlikely that the participant will
comply with the protocol or complete the study per protocol.
13. Participant has received any of the following vaccinations:
1. Live vaccine(s) within 1 month prior to Screening or plans to receive such
vaccines during the study.
2. Killed vaccine 1 week prior to Screening.
3. COVID-19 vaccine Day -7 through to Visit 4.
14. Participant had surgery of the nose/paranasal sinuses/mouth/throat within 8 weeks
prior to Screening.
15. Participant has any clinically relevant respiratory (especially with reduction of
respiratory capacity) or cardiovascular abnormality (eg, high blood pressure,
myocardial infarction in previous 3 months, etc), or any other abnormality that in the
opinion of the Investigator may pose a safety risk to a participant in this study, may
confound the clinical performance or safety assessment, or may interfere with study
participation.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/06/2022
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Q-Pharm Pty Ltd - Herston
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Recruitment postcode(s) [1]
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4006 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
De Motu Cordis
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Novotech (Australia) Pty Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study to determine the relative bioavailability of inhaled epinephrine compared
with 0.3mg epinephrine administered IM in healthy male and female participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05152901
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter O'Neill
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Address
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[email protected]
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05152901
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