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Safety, pharmacokinetics and pharmacodynamics of the selective glucocorticoid receptor modulator AZD7594, following inhalation in healthy Japanese volunteers
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Safety, pharmacokinetics and pharmacodynamics of the selective glucocorticoid receptor modulator AZD7594, following inhalation in healthy Japanese volunteers
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Safety, pharmacokinetics and pharmacodynamics of the selective glucocorticoid receptor modulator AZD7594, following inhalation in healthy Japanese volunteers
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Journal Article
Safety, pharmacokinetics and pharmacodynamics of the selective glucocorticoid receptor modulator AZD7594, following inhalation in healthy Japanese volunteers
2019
Overview
AZD7594 is a non-steroidal, selective, glucocorticoid receptor modulator (SGRM), currently in development for the treatment of asthma and chronic obstructive pulmonary disease. This paper reports a randomized placebo-controlled dose escalation study in healthy Japanese male subjects.
Inhaled AZD7594 was administered as one single dose at day 1 (day 1-4), with subsequent multiple daily doses (day 5-16) via a multiple-dose dry powder inhaler for 12 days of once-daily treatment. At each dose level, subjects were randomized to AZD7594 (n=7) or placebo (n=2). The safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594 were evaluated.
Inhaled AZD7594 was safe and well tolerated up to and including the highest dose 1600 µg tested. Plasma exposure suggested dose-proportional PK. The urinary excretion of AZD7594 was negligible (<0.02%). Dose-related effects were observed for 24 hrs plasma cortisol; however, significant cortisol suppression (25%) was only seen at the highest dose level following multiple doses. There were no or only marginal effects on other biomarkers tested (dehydroepiandrosterone sulfate [DHEA-S] and osteocalcin).
In conclusion, the early clinical evaluation of inhaled AZD7594 suggests that this novel SGRM is well tolerated in the dose range investigated and also in a Japanese population. It shows dose-proportional plasma exposure, moderate accumulation and has limited impact on systemic markers of glucocorticoid activity.
Publisher
Dove Medical Press Limited,Taylor & Francis Ltd,Dove Press,Dove,Dove Medical Press
Subject
/ Adult
/ Asthma
/ AZD7594
/ Benzamides - administration & dosage
/ Benzamides - pharmacokinetics
/ Chronic obstructive lung disease
/ Chronic obstructive pulmonary disease
/ Dehydroepiandrosterone sulfate
/ Dose-Response Relationship, Drug
/ Enzymes
/ Exposure
/ glucocorticoid receptor modulator
/ Hormones
/ Humans
/ Japan
/ Japanese
/ Male
/ Novels
/ Protein Kinase Inhibitors - administration & dosage
/ Protein Kinase Inhibitors - analysis
/ Protein Kinase Inhibitors - pharmacokinetics
/ Pulmonary Disease, Chronic Obstructive - drug therapy
/ Pulmonary Disease, Chronic Obstructive - metabolism
/ Pyrazines - administration & dosage
/ Pyrazines - pharmacokinetics
/ Receptors, Glucocorticoid - metabolism
/ Safety
/ SGRM
/ Sulfates
/ Urine
