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

NCT ID: NCT05625334

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2023-03-09

Brief 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.

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: I-ASA 100mg, then C-ASA 162mg tablet

Treatment 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).

Group Type: EXPERIMENTAL

ASA

Intervention Type: DRUG

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

non-enteric-coated chewable aspirin

Intervention Type: DRUG

Orally administered

Arm 2: C-ASA 162mg tablet, then I-ASA 100mg

Treatment 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.

Group Type: EXPERIMENTAL

ASA

Intervention Type: DRUG

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

non-enteric-coated chewable aspirin

Intervention Type: DRUG

Orally administered

Interventions

ASA

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

Intervention Type: DRUG

non-enteric-coated chewable aspirin

Orally administered

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Healthy as defined by:

1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.

2. 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.

3. Female subjects of non-childbearing potential must be:

1. post-menopausal OR

2. surgically sterile at least 3 months prior to dosing.

4. Sexually active female subjects of childbearing potential must be willing to use an acceptable contraceptive method throughout the study as defined in the protocol.

5. 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.

6. Agrees to refrain from alcohol consumption for at least 48 hours prior to admission and 48 hours after drug administration of each period.

7. Able to understand the study procedures and provide signed informed consent to participate in the study.

Exclusion Criteria

1. Any clinically significant abnormal finding at physical examination at screening.

2. Positive serology test results for HBsAg, HCV antibody, or HIV antigen and antibody, at screening.

3. Positive pregnancy test or lactating female subject.

4. Positive urine drug screen, urine cotinine test, or alcohol breath test.

5. Known allergic reactions, hypersensitivity or contraindications to aspirin (ASA), ibuprofen, other NSAIDs, or other related drugs, or to any excipient in the formulation.

6. Known lack of response (lack of effect) to aspirin in the past.

7. Clinically significant x-ray, ECG abnormalities or vital signs abnormalities at screening.

8. Clinically significant abnormal laboratory parameters including:

1. Hematocrit value ≤ 32%;

2. Platelet count <142,000 or > 450,000 platelets per µL;

3. ALT ≥ 3 x ULN;

4. AST ≥ 3 x ULN.

9. 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.

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Vectura, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sinai Hospital

Baltimore, Maryland, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO

Springfield, Missouri, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 32986482 (View on PubMed)

Other Identifiers

BORA-1A-C301

Identifier Type: -

Identifier Source: org_study_id