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A Study to Evaluate the Disposition of Drug in Body and Safety After Administration of Single Inhaled Doses of Drugs Abediterol and AZD7594 Administered Alone, in Fixed Dose Combination and in Free Combination Using the Dry Powder Inhaler in Healthy Male Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Disposition of Drug in Body and Safety After Administration of Single Inhaled Doses of Drugs Abediterol and AZD7594 Administered Alone, in Fixed Dose Combination and in Free Combination Using the Dry Powder Inhaler in Healthy Male Participants

A RANDOMIZED OPEN LABEL CROSS-OVER STUDY TO EVALUATE PHARMACOKINETICS AND SAFETY OF SINGLE INHALED DOSES OF ABEDITEROL AND AZD7594 GIVEN ALONE, IN FIXED DOSE COMBINATION (FDC) AND IN FREE COMBINATION, USING DPI, IN MALE HEALTHY VOLUNTEERS

NCT02967159•AstraZeneca

View on ClinicalTrials.gov

Summary

AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary disease (COPD) and asthma. Abediterol is a novel and selective β2 adrenergic receptor agonist with the potential for once daily treatment of asthma and COPD in fixed dose combination (FDC) with an ICS or a novel anti inflammatory (AI) agent. This study will be the first clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC or in free combination via 2 separate dry powder inhalers (DPIs). This study will be conducted in healthy male subjects to minimize the effects of concomitant disease states or medications on study measurements.

Detailed Description

AZD7594 is a non steroidal, potent and selective modulator of the glucocorticoid receptor (GR) under development for once daily inhaled treatment of chronic obstructive pulmonary disease (COPD) and asthma. Inhaled corticosteroids (ICS) have not been definitively shown to decrease the rate of decline in lung function that is typical of COPD. The aim is to develop AZD7594 as a well tolerated once daily selective inhaled GR modulator with an acceptable side effect profile compared to conventional ICS on the market. Abediterol is a novel and selective β2 adrenergic receptor agonist with the potential for once daily treatment of asthma and COPD in fixed dose combination (FDC) with an ICS or a novel anti inflammatory (AI) agent Fixed dose ICS/LABA combination treatment is more effective in improving lung function, health status and reducing exacerbations than the individual components. The long term goal of abediterol development program in COPD is to investigate it both as a monotherapy and as a combination therapy in conjunction with an ICS or a novel anti inflammatory agent. This study will be the first clinical study for the combination exposure of AZD7594 with abediterol as 2 compounds in FDC or in free combination via 2 separate dry powder inhalers (DPIs). This study will be conducted in healthy male subjects to minimize the effects of concomitant disease states or medications on study measurements. Subjects will receive all 4 treatments in a randomized order. Given that the treatment in each period is a single dose of AZD7594, a 21 (±2) day wash out should be adequate to prevent carry over effect to next period. The abediterol elimination half life is shorter than that of AZD7594. Therefore, a 21 (±2) day wash out is sufficient for the elimination of both AZD7594 and abediterol. Overall, pre-clinical and clinical data generated to date with abediterol show expected safety profile, and support the continued studies with abediterol.

Eligibility

Age

18 - 55 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 to 55 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. Subjects should be willing to follow reproductive restrictions #11 in Section 7.47.4.1 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 IMP.
•5. Be able to inhale from the DPI devices according to given instructions.
•6. Able to understand, read and speak the German language.

Exclusion Criteria

•1. 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.
•2. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
•3. Known Gilbert's syndrome, family history of Gilbert's syndrome or suspicion of Gilbert's syndrome based on liver function tests.
•4. Any contraindication against the use of vagolytic or sympaticomimetic drugs, as judged by the Investigator.
•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, as judged by the Investigator.
•7. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti HBc Ab), hepatitis C antibody and human immunodeficiency virus (HIV).
•8. Abnormal vital signs, after 10 minutes supine rest (confirmed by 1 controlled measurement), defined as any of the following:
•* Systolic BP (SBP) \< 90 mmHg or ≥ 140 mmHg
•* Diastolic BP (DBP) \< 50 mmHg or ≥ 90 mmHg
+23 more criteria

Locations (1)

Research Site

Berlin, Germany

Key Dates

Start Date

November 24, 2016

Primary Completion Date

April 6, 2017

Completion Date

April 6, 2017

Last Updated

February 13, 2018

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Asthma

Interventions

Abediterol

DRUG

AZD7594

DRUG

AZD7594/abediterol

DRUG

AZD7594 and abediterol

DRUG

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RECRUITINGPHASE2

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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: February 13, 2018Data 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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A Study to Evaluate the Disposition of Drug in Body and Safety After Administration of Single Inhaled Doses of Drugs Abediterol and AZD7594 Administered Alone, in Fixed Dose Combination and in Free Combination Using the Dry Powder Inhaler in Healthy Male Participants

Inclusion Criteria

Exclusion Criteria

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