Relative bioavailability study with Abediterol administered via three different inhalation devices in Healthy Volunteers.

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.
• 16 Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as
• judged by the PI or positive screen for drugs of abuse, cotinine, and/or alcohol at
• screening or on each admission to the Clinical Unit.
• 17 Subjects with a pregnant partner.
• 18 Involvement of any AstraZeneca, Parexel or study site employee or their close
• relatives.
• 19 Subjects who have previously received abediterol.
• 20 Judgement by the PI that the subject should not participate in the study if they have
• any ongoing or recent (i.e., during the screening period) minor medical complaints
• that may interfere with the interpretation of study data or are considered unlikely to
• comply with study procedures, restrictions, and requirements.
• 21 Vulnerable subjects, e.g., kept in detention, protected adults under guardianship,
• trusteeship, or committed to an institution by governmental or juridical order.