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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05152901




Registration number
NCT05152901
Ethics application status
Date submitted
9/11/2021
Date registered
10/12/2021

Titles & IDs
Public title
Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
Scientific title
A Phase 1 Comparative Bioavailability Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults
Secondary ID [1] 0 0
CTP-00070-00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaphylactic Reaction 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by Regulatory Activities (MedDRA) Version 22.0 or higher.
Timepoint [1] 0 0
Screening through to follow up so approx. 66 days
Primary outcome [2] 0 0
Safety and tolerability of inhaled epinephrine in healthy participants measured through percentage of subjects with abnormal and clinically significant abnormal hematology values.
Timepoint [2] 0 0
Screening through to follow up so approx. 66 days
Primary outcome [3] 0 0
Safety and tolerability of inhaled epinephrine in healthy participants measured through PR interval in ECG Assessment.
Timepoint [3] 0 0
Screening through to follow up so approx. 66 days
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Screening through to follow up so approx. 66 days
Primary outcome [5] 0 0
Safety and tolerability of inhaled epinephrine in healthy participants measured through Functional Vital Capacity (FVC) in the Lung Function test assessment.
Timepoint [5] 0 0
Screening through to follow up so approx. 66 days
Secondary outcome [1] 0 0
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through time to maximum observed epinephrine concentration (Tmax).
Timepoint [1] 0 0
Day 1, Day 2, Day16 and Day 30
Secondary outcome [2] 0 0
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants by plasma concentration-time profiles (Cmax).
Timepoint [2] 0 0
Day 1, Day 2, Day16 and Day 30
Secondary outcome [3] 0 0
To determine the plasma pharmacokinetics (PK) of inhaled epinephrine in healthy participants through Area under curve (AUC0-t).
Timepoint [3] 0 0
Day 1, Day 2, Day16 and Day 30
Secondary outcome [4] 0 0
To determine the comparative plasma bioavailability of inhaled epinephrine to intramuscular (IM)epinephrine in healthy participants.
Timepoint [4] 0 0
Day 1, Day 2, Day16 and Day 30

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]).
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/06/2022
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
De Motu Cordis
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter O'Neill
Address 0 0
[email protected]
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05152901