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AzTrials

Healthy VolunteersPhase 1NCT05625334

Study to Compare the Pharmacodynamics and Pharmacokinetics of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Healthy Adults.

A Phase 1 study testing ASA and non-enteric-coated chewable aspirin in people with Healthy Volunteers, run by Vectura, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to compare the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of acetylsalicylic acid powder for oral inhalation (i-ASA) with non-enteric-coated chewable aspirin (C-ASA) in healthy adults by demonstrating bioequivalence. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
ASA and non-enteric-coated chewable aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
2 sitesUnited States
Study dates
14 Oct 2022to 9 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female, ≥18 and ≤55 years of age, with BMI >18.5 and <32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
  • Healthy as defined by:
  • the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
  • the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, respiratory, hematological (e.g., thrombocytopenia, neutropenia, bleeding disorders), immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
  • Female subjects of non-childbearing potential must be:
  • post-menopausal OR
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  • surgically sterile at least 3 months prior to dosing.
  • Sexually active female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study as defined in the protocol.
  • Current non-smoker: no use of tobacco or nicotine products, including any smoking cessation nicotine-containing products (i.e., nicotine replacement therapy [patch, spray, inhaler, gum, lozenge, bupropion SR, clonidine and nortriptyline], e-cigarettes, etc.) for at least 3 months prior to screening.
  • Agrees to refrain from alcohol consumption for at least 48 hours prior to admission and 48 hours after drug administration of each period.
  • Able to understand the study procedures and provide signed informed consent to participate in the study.

Who cannot join

  • Any clinically significant abnormal finding at physical examination at screening.
  • Positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.
  • Positive pregnancy test or lactating female subject.
  • Positive urine drug screen, urine cotinine test, or alcohol breath test.
  • Known allergic reactions, hypersensitivity or contraindications to aspirin (ASA), ibuprofen, other NSAIDs, or other related drugs, or to any excipient in the formulation.
  • Known lack of response (lack of effect) to aspirin in the past.
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  • Clinically significant x-ray, ECG abnormalities or vital signs abnormalities at screening.
  • Clinically significant abnormal laboratory parameters including:
  • Hematocrit value ≤ 32%;
  • Platelet count <142,000 or > 450,000 platelets per µL;
  • ALT ≥ 3 x ULN;
  • AST ≥ 3 x ULN.
  • Subject with abnormal lung function defined by spirometric testing such that: the post bronchodilator FEV1 < 80% of predicted normal value OR FEV1/FVC ratio < 0.70.
  • Subject with current asthma defined as post-bronchodilator FEV1 > 12% increase AND > 200 ml absolute increase from pre-bronchodilator values.
  • Other protocol-defined I/E criteria that apply.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sinai Hospital

    Baltimore, Maryland, 21215

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO

    Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Single-dose, Open-label, Randomized, Multi-center, 2-treatment Crossover Study to Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Acetylsalicylic Acid Powder for Oral Inhalation With Non-enteric-coated Chewable Aspirin in Healthy Adults

The goal of this clinical trial is to compare the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of acetylsalicylic acid powder for oral inhalation (i-ASA) with non-enteric-coated chewable aspirin (C-ASA) in healthy adults by demonstrating bioequivalence.

In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.

Being tested
ASA, non-enteric-coated chewable aspirin
Keywords
ASA, acetylsalicylic acid, cyclooxygenase-1 enzyme, oral inhalation, inhaled, myocardial Infarction
Medical subject headings
Respiratory Aspiration, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASADrug

    powder for oral inhalation via a Dry Powder Inhaler (DPI)

  • non-enteric-coated chewable aspirinDrug

    Orally administered

Study groups in NCT05625334
Study groupRoleWhat they receive
Arm 1: I-ASA 100mg, then C-ASA 162mg tabletExperimentalTreatment A: Single dose of 100 mg ASA powder for oral inhalation (I-ASA) via DPI. Treatment B: Single dose of 162 mg chewable non-enteric-coated Aspirin (C-ASA).
Receives: Drug: ASA; Drug: non-enteric-coated chewable aspirin
Arm 2: C-ASA 162mg tablet, then I-ASA 100mgExperimentalTreatment B: Single dose of 162 mg chewable non-enteric-coated Aspirin (C-ASA). Treatment A: Single dose of 100 mg ASA powder for oral inhalation (I-ASA) via DPI.
Receives: Drug: ASA; Drug: non-enteric-coated chewable aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression)

    Measured: 24 hours post-dose

Secondary outcomes (11)

  1. Proportion of subjects achieving significant inhibition of platelet aggregation (<550 Aspirin Reaction Units [ARU])

    Measured: 2 minutes post-dose

  2. TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)

    Measured: 20 minutes post-dose.

  3. TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)

    Measured: 30 minutes post-dose

  4. Time to significant inhibition of platelet aggregation (<550 ARU).

    Measured: assessed up to 24 hours post-dose

  5. Peak plasma concentrations (Cmax) of ASA

    PK endpoints

    Measured: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440

  6. Peak plasma concentrations (Cmax) of SA

    PK endpoints

    Measured: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440

  7. Area under the plasma concentration versus time curve (AUC0-inf)

    PK endpoints

    Measured: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440

  8. Area under the plasma concentration versus time curve (AUC0-t)

    PK endpoints

    Measured: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440

  9. Time to peak plasma concentrations (Tmax) of ASA

    PK endpoints

    Measured: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440

  10. Time to peak plasma concentrations (Tmax) of SA

    PK endpoints

    Measured: pre-dose. minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 360, 480, 720 and 1440

  11. Incidence and frequency of Adverse Events.

    Measured: screening through the 7-day to follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2022
  2. Study start14 Oct 2022
  3. Primary completion9 Mar 2023
  4. Study completion9 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05625334
Sponsor's protocol ID
BORA-1A-C301
Status last verified
Mar 2024
First submitted
1 Nov 2022
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gurbel PA, Bliden KP, Chaudhary R, Tantry US. First In-Human Experience With Inhaled Acetylsalicylic Acid for Immediate Platelet Inhibition: Comparison With Chewed and Swallowed Acetylsalicylic Acid. Circulation. 2020 Sep 29;142(13):1305-1307. doi: 10.1161/CIRCULATIONAHA.120.047477. Epub 2020 Sep 28. No abstract available.

    PubMed 32986482

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ASA and non-enteric-coated chewable aspirin in people with Healthy Volunteers, run by Vectura, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression) (time frame: 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05625334, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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