A Study to Assess the Bioavailability and to Compare the Pharmacokinetics of AZD7594 Inhaled Via Monodose Inhaler and Multiple-dose Dry Powder Inhalers (DPI) or Pressurized Metered-dose Inhaler (pMDI) in Healthy Male Subjects

Completed · Phase 1

Conditions studied: Asthma, Chronic Obstructive Pulmonary Disease (COPD)

In brief

This is an open-label,partially randomized, four-period study in healthy male subjects to assess the bioavailability and pharmacokinetics of a single dose of AZD7594 when administered intravenously, orally and inhaled via two different dry powder inhalers (DPIs) and a pressurized meter-dose inhaler (pMDI)

Key facts

Study ID

NCT02648438

Run by

AstraZeneca

People needed

30

Starts

2016-01-12

Expected to finish

2016-06-01

Last updated by the study team

2017-06-15

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venipuncture.
• Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.
• Subjects should be willing to follow reproductive restrictions to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of investigational product.
• Be able to inhale from the dry powder inhaler (DPI) devices and the pressurized metered-dose inhaler (pMDI) device according to given instructions.

You may not qualify if…

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, 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.
• History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically significant illness, major medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening and check-in, as judged by the investigator.
• Any clinically significant abnormal findings in vital signs after a 5 minute rest at screening and check-in, as judged by the investigator, defined as any of the following:
• Systolic blood pressure (BP) > 140 mm Hg;
• Systolic BP < 90 mm Hg;
• Diastolic BP > 90 mm Hg;
• Diastolic BP < 60 mm Hg; or
• Heart rate < 40 or > 85 beats per minute (bpm).
• Any clinically significant abnormities in physical examination or lung function, as judged by the investigator.
• Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening and check-in, as judged by the investigator.
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc (QT interval corrected) interval changes. This includes subjects with any of the following:
• Clinically significant PR (PQ) (ECG interval measured from the onset of the P wave to the onset of the QRS complex) interval prolongation;
• Intermittent or persistent second or third degree AV block;
• Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS (ECG interval measured from the onset of the QRS complex to the J point) > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation; or
• Abnormal T wave morphology, particularly in the protocol defined primary lead.
• Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) > 450 msec or family history of long QT (ECG interval measured from the onset of the QRS complex to the end of the T wave) syndrome.
• Known or suspected history of drug abuse, as judged by the investigator
• Current smokers or those who have smoked or used nicotine products within the previous 3 months.
• History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
• Positive screen for drugs of abuse, alcohol, and cotinine at screening or on each admission to the study center.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7594 or to excipients.
• Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (in total no more than 3 cups per day).
• Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.

Where it is running

• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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