To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients

AstraZeneca52 enrolled

Overview

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary disease.

A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients with COPD

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

COPD Healthy Subjects

Interventions

AZD7624DRUG

Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer

Placebo to matchDRUG

Multiple doses inhaled placebo via a nebulizer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * Provision of signed and dated, written informed consent prior to any study specific procedures * Plasma myoglobin and CK not above the upper reference range of the analysing laboratory at Day -1 * Male and/or female patients with COPD aged above18 years with suitable veins for cannulation or repeated venipuncture. * Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines Exclusion Criteria: * Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP * Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the IP in this study * Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator * Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

Adverse Events

Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)

Time frame: Up to 24 days

Secondary Outcomes

Summary of Pharmacokinetic Parameters (AUC(0-tau) )

Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. \*AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours . Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken.

Time frame: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.

Summary of Pharmacokinetic Parameters (Cmax)

Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken.

Summary of Pharmacokinetic Parameters (Cmin)

Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device). Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken.

Data from ClinicalTrials.gov

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