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Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers. | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers.

An Open-label, Single-center, Randomized, 4-period, Single Dose, Crossover Study to Assess the Relative Bioavailability of Abediterol Inhaled Via Two Different Nebulizers and Via Dry Powder Inhaler in Healthy Subjects.

NCT04199598•AstraZeneca

View on ClinicalTrials.gov

Summary

The study is intended to assess the relative bioavailability of 2 different abediterol nebulised formulations (test) and the dry powder formulation (reference). The study results will provide information on the pharmacokinetic (PK) profile following use of the 3 devices to be used in further clinical development.

Detailed Description

This study will be an open-label, randomized, 4-period, single-dose, single-center, crossover study with a William's design in healthy subjects (males). The study will comprise: 1. A screening period of maximum 28 days; 2. Four treatment periods during which subjects will be resident prior to the evening meal the night before dosing with abediterol (Day -1) until at least 48 hours following dosing for collection of PK samples; discharged on the morning of Day 3; and 3. A final safety post-treatment visit within 14 days after the last administration of abediterol. There will be a minimum washout period of 14 days between each treatment period. Each subject will be involved in the study for approximately 12 weeks.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Provision of signed and dated, written informed consent prior to any study-specific procedures.
•2. Healthy male subjects aged 18 - 45 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
•3. Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
•4. Subject is able to understand and communicate in German.
•5. Willing and able to comply with all required study procedures.

Exclusion Criteria

•1. History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
•2. History or presence of gastrointestinal (GI), hepatic or renal disease, or any other conditions (e.g., including Gilbert's syndrome, gallstone and cholecystectomy) known to interfere with absorption, distribution, metabolism, or excretion of drugs.
•3. History of tuberculosis, any other significant lung diseases like surgeries, asthma, COPD.
•4. Upper respiratory tract infections within 14 days of the first study day, or lower respiratory tract infection within 3 months prior to screening.
•5. Any clinically significant illness, medical/surgical procedure, or trauma within
•4 weeks of the first administration of IMP. 6 Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and first admission to the study unit (first treatment period) as judged by the PI. 7 Any clinically significant abnormal findings in vital signs at screening and first admission to the study unit (first treatment period), as judged by the PI, and defined as:
•1. Systolic BP \<90 mmHg or ≥140 mmHg and diastolic BP \<50 mmHg or
•≥90 mmHg
•2. Heart rate \<50 beats per minute \[bpm\] or \>90 bpm Note: Assessments may be repeated once to confirm values. 8 Any clinically significant abnormalities on 12-lead ECG at screening and first admission to the study unit (first treatment period), as judged by the PI, and defined as:
•(1) Sick sinus syndrome (2) Arrhythmia (3) Prolonged QT interval corrected using Fridericia's formula (QTcF) \> 450 ms (4) Family history of long QT syndrome, persistent or intermittent bundle branch block (BBB), AV block grade II or III 9 Any positive result on screening for serum hepatitis B surface antigen (HBsAg) OR anti-hepatitis B core antigen (HBc) antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody. 10 Has received another new chemical and biologic entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded. 11 Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening. 12 History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to abediterol. 13 Current smokers or those who have smoked or used nicotine products (including e- cigarettes; \> 10 pack-year) within the 3 months prior to screening. 14 Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP. 15 Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
+1 more criteria

Locations (1)

Research Site

Berlin, Germany

Key Dates

Start Date

January 28, 2020

Primary Completion Date

April 3, 2020

Completion Date

April 3, 2020

Last Updated

April 21, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Abediterol (2.4 μg)

DRUG

Abediterol (4.8 μg)

DRUG

Abediterol (2.4 μg)

DRUG

Abediterol (2.5 μg)

DRUG

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Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

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NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers.

Inclusion Criteria

Exclusion Criteria

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