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Platelet Aggregation InhibitorsPhase 1NCT04328883

Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin

A Phase 1 study testing Aspirin in people with Platelet Aggregation Inhibitors, run by Inova Health Care Services at 1 site 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

ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI), an FDA approved indication for oral formulations of aspirin. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Platelet Aggregation Inhibitors
What is being tested?
Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
16 Jul 2019to 10 Oct 2019
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 subjects, 18-55 years of age
  • Non-smokers
  • Body mass index (BMI) within 18.5 kg/m2 to 32.0 kg/m2
  • Female subjects of childbearing potential must agree to use acceptable methods of birth control or abstain from sex during study participation and must have a negative serum or urine pregnancy test
  • Subjects must be healthy as determined by medical history, physical examination, vital signs, and clinical laboratory evaluation
  • Signed informed consent

Who cannot join

  • At screening visit, subjects with a forced expiratory volume in 1 second (FEV1) (i.e., FEV1% predicted < 80%).
  • At screening visit, subjects with a forced expiratory flow at 25%-75% (FEF 25%-75%) of pulmonary volume < 70% predicted.
  • Patients with a flow rate <70 L/min with a G-16 training device set at medium resistance.
  • Hematocrit value ≤32%
  • Clinically significant hemoglobin value, at screening, as per investigator.
  • Arachidonic acid induced-maximum platelet aggregation <50%.
Show all 25Show fewer
  • Platelet count <142,000 or > 450,000 µL.
  • Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study drug administration.
  • Presence of braces, partials or dentures.
  • Clinically significant abnormal laboratory parameters.
  • Antiplatelet agents (ASA, NSAID's, P2Y12 inhibitors, etc.) within 10 days of dosing visit.
  • HIV, hepatitis B or C infection.
  • Presence of clinically significant cardiovascular, pulmonary, hepatic, renal, endocrinological, hematological, immunologic, metabolic, neurological, or gastrointestinal disease.
  • Clinically significant physical examination.
  • History of hypersensitivity or allergy to aspirin.
  • History of significant bleeding disorders.
  • History of peptic ulcer disease.
  • History of asthma or chronic obstructive pulmonary disease.
  • Concurrent corticosteroid use with the exception of topical; any previous use must have occurred at least 90 days prior to Day 1 of the study and be approved by the Investigator.
  • Administration of any prescription/over the counter medications/herbal/nutritional supplements within 14 days that has an effect on platelets prior to visit1 of the study.
  • Administration of any investigational drug product (IP) within 30 days prior to visit 1.
  • ALT ≥ 3xULN.
  • Total Bilirubin > 1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
  • Donation of blood or platelets within 60 days prior to visit 1.
  • Any condition, illness, or disease that in the opinion of the investigator would interfere with the subject's ability to comply with the requirements of this protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

Other trials in United States

About this study

Official title: A Phase 1, Single-dose, Open-label, Pilot Study to Compare the Pharmacodynamics and Pharmacokinetics of Acetylsalicylic Acid Inhalation Powder With Non-Enteric-Coated Chewable Aspirin in Healthy Adults

ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI), an FDA approved indication for oral formulations of aspirin.

The primary goal of study OTP-P0-926 is to collect pharmacokinetic (PK)and pharmacodynamics (PD) pilot data to determine onset and extent of aspirin response after administration of varying doses of inhaled ASA (50-100mg) and 162 mg Non-Enteric-Coated Chewable ASA. PD will be assessed using standard methods to measure platelet inhibition by aspirin including platelet aggregation, serum thromboxane,and urinary thromboxane. Furthermore, the pharmacokinetics (PK) of ASA will be determined and compared to PD measurements. Results of this pilot study will guide dosing in a subsequent larger Phase II study.

Being tested
Aspirin

What participants receive

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

  • AspirinDrug

    Also called Bayer Aspirin

    Oral and inhaled ASA formulations

Study groups in NCT04328883
Study groupRoleWhat they receive
162 mg Non-Enteric-Coated Chewable aspirinActive comparatorNon-enteric coated aspirin (162mg, single dose)
Receives: Drug: Aspirin
50 mg ASA inhalation powderExperimentalDry powder inhaled aspirin (50mg,1 dry powder inhalation capsule using dry powder inhaler, single dose)
Receives: Drug: Aspirin
100 mg ASA inhalation powderExperimentalDry powder inhaled aspirin (100mg,1 dry powder inhalation capsule using dry powder inhaler, single dose)
Receives: Drug: Aspirin

What is being measured

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

  1. Compare the onset and extent of the pharmacodynamic effect of ASA inhalation powder (50-100 mg) and chewed non-enteric coated aspirin (162 mg) on arachidonic acid (AA)-induced platelet aggregation.

    Change from pre-dose in 1mM arachidonic-induced platelet aggregations at 2, 5, 10, 20,30, 40 minutes and 1,4, and 24hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.

    Measured: 24 hours

Secondary outcomes (8)

  1. Compare the onset and extent of the pharmacodynamic effect of ASA inhalation powder and chewed non-enteric coated aspirin on ADP-induced platelet aggregation.

    Change from pre-dose on 5uM ADP-induced platelet aggregation at 2, 5, 10, 20,30, 40 minutes and 1,4, and 24hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.

    Measured: 24 hours

  2. Compare the onset and extent of the pharmacodynamic effect of ASA inhalation powder and chewed non-enteric coated aspirin on Collagen-induced platelet aggregation.

    Change from pre-dose on 4ug Collagen-induced platelet aggregation at 2, 5, 10, 20,30, 40 minutes and 1,4, and 24hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.

    Measured: 24 hours

  3. Compare the onset and extent of the pharmacodynamic effect of ASA inhalation powder and chewed non-enteric coated aspirin on serum concentrations of thromboxane B2 (TxB2).

    Change from pre-dose on serum concentrations of TxB2 at 2, 5, 10, 20,30, 40 minutes and 1,4, and 24hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.

    Measured: 24 hours

  4. Compare the onset and extent of the pharmacodynamic effect of ASA inhalation powder and chewed non-enteric coated aspirin on 6-keto- PGI1α.

    Change from pre-dose on 6-keto- PGI1α at 2, 5, 10, 20,30, 40 minutes and 1,4, and 24hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.

    Measured: 24 hours

  5. Compare the extent of the pharmacodynamic effect of ASA inhalation powder and chewed non-enteric coated aspirin on urinary 11-dehydro TxB2.

    Change from pre-dose on urinary 11-dehydro TxB2 at 4, and 24 hours after dosing with 50, 100mg aspirin dry powder inhalation and 162mg chewed non-enteric coated aspirin.

    Measured: 24 hours

  6. Compare the time to maximum drug concentration (Tmax) on ASA and salicylic acid (SA) pharmacokinetics following single doses of ASA inhalation powder and oral (Non-Enteric-Coated Chewable ) aspirin

    Compare Tmax between treatment groups

    Measured: 24 hours

  7. Compare the maximum drug concentration (Cmax) on ASA and salicylic acid (SA) pharmacokinetics following single doses of ASA inhalation powder and oral (Non-Enteric-Coated Chewable ) aspirin

    Compare Cmax between treatment groups

    Measured: 24 hours

  8. Evaluate change in forced expiratory-1 (FEV-1) after a single dose of acetylsalicylic acid (ASA) inhalation powder administered as ASA inhalation powder

    Evaluate change in forced expiratory-1 (FEV-1) from pre-dose measures after a single dose of acetylsalicylic acid (ASA) inhalation powder administered as ASA inhalation after 4 and 24hours post dosing.

    Measured: 24 hours

Timeline

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

  1. First posted1 Apr 2020
  2. Study start16 Jul 2019
  3. Primary completion3 Oct 2019
  4. Study completion10 Oct 2019

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04328883
Sponsor's protocol ID
InovaHCS
Status last verified
Dec 2019
First submitted
9 Dec 2019
Last updated
1 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gurbel PA, Bliden KP, Tantry US. Defining platelet response to acetylsalicylic acid: the relation between inhibition of serum thromboxane B2 and agonist-induced platelet aggregation. J Thromb Thrombolysis. 2021 Feb;51(2):260-264. doi: 10.1007/s11239-020-02334-x. Epub 2020 Nov 10.

    PubMed 33170486

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Aspirin in people with Platelet Aggregation Inhibitors, run by Inova Health Care Services at 1 site 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 6 inclusion and 25 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Compare the onset and extent of the pharmacodynamic effect of ASA inhalation powder (50-100 mg) and chewed non-enteric coated aspirin (162 mg) on arachidonic acid (AA)-induced platelet aggregation. (time frame: 24 hours). 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 NCT04328883, 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 1 Apr 2020.

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