A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men

Completed · Phase 1 · Has a placebo group

Conditions studied: Asthma, Chronic Obstructive Pulmonary Disease COPD

In brief

This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics \[PD\]) and how the body affects the drug (pharmacokinetics \[PK\]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)

Key facts

Study ID

NCT02645253

Run by

AstraZeneca

People needed

27

Starts

2016-01-12

Expected to finish

2016-04-17

Last updated by the study team

2018-02-19

Who can join

Age: 20 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 Japanese subjects aged 20 to 45 years with suitable veins for cannulation or repeated venipuncture.
• A Japanese male subject is defined as being born in Japan, having both parents and four grandparents who are Japanese. The subject must not have lived outside of Japan for more than 5 years.
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg inclusive.
• Provision of signed, written and dated informed consent for optional genetic research Note: If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.

You may not qualify if…

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject'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, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational drug administration.
• Any contraindication against the use of vagolytic or sympaticomimetic drugs, as judged by the investigator.
• Any clinically significant abnormalities in clinical chemistry, hematology, urinalysis, physical examination, vital signs, electrocardiogram (ECG) or lung function results at baseline, as judged by the investigator.
• Known Gilbert's syndrome, family history of Gilbert's syndrome or suspicion of Gilbert's syndrome based on liver function tests.
• Use of systemic glucocorticosteroids within 6 weeks of enrollment.
• Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV).
• Known or suspected hypersensitivity to investigational product or excipients.
• Plasma donation within one month of screening or any blood donation/blood loss > 500 mL during the 3 months prior to screening.
• Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
• Systolic blood pressure (BP) < 90mmHg or > 140 mmHg
• Diastolic BP < 60mmHg or > 90 mmHg
• Pulse rate < 40 or > 85 beats per minute (bpm)
• Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
• Prolonged QT interval corrected for heart rate (HR) using Fridericia's formula (QTcF) > 450 ms or family history of long QT syndrome.
• PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
• PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation.
• Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 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.
• 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 or cotinine (nicotine) at screening or admission to the unit.
• History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to ADZ7594.
• Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator.

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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