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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817855
• Other study ID #: D2550C00002
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2013
• Last updated: December 9, 2014
• Start date: September 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• COPD
• Healthy Subjects

Intervention

Drug:
• AZD7624
Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer
• Placebo to match
Multiple doses inhaled placebo via a nebulizer

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline up to 66 days in safety variables (adverse events, vital signs, body temperature, physical exams, ECGs, telemetry, clinical laboratory safety tests and spirometry).	Cohorts 1 and 4: Study duration [from screening visit (Day -42) through follow up visit (up to Day 22) at multiple timepoints up to 64 days] Cohorts 2 and 3: Study duration [from screening visit (Day -42) through follow up visit (up to Day 24) at multiple timepoints up to 66 days]	Up to 66 days	Yes
Secondary	AZD7624 single dose pharmacokinetics profile from blood in healthy volunteers (cohorts 1, 2 and 3) and COPD patients (cohort 4).	PK parameters: Cmax, tmax, ?z; t1/2, area under the plasma concentration-time curve from zero to 24 hours [AUC(0-24)], from zero to the time of the last measurable concentration [AUC(0-last)] and from zero to infinity (AUC), CL/F and Vz/F	Day 1 and 8 (cohort 1), Day 1 and 9 (cohort 2 and 3), Day 1 and 7 (cohort 4): pre-dose, 5, 15 and 30 min, 1, 2, 3, 4, 6, 9, 12, 18 and 24 hrs (and 36, 48 and 72 hrs following dosing Day 1 for cohort 2 and 3)	No
Secondary	AZD7624 multiple dose pharmacokinetics profile from blood in healthy volunteers (cohorts 1, 2 and 3) and COPD patients (cohort 4).	PK parameters: Cmax, tmax, Cmin, area under the plasma concentration-time curve from zero to the end of the dosing interval [AUC(0-t)], CL/F, extent of accumulation on multiple dosing (RCmax and RAUC), and time dependency of the pharmacokinetics.	Day 1 and 8 (cohort 1), Day 1 and 9 (cohort 2 and 3), Day 1 and 7 (cohort 4): pre-dose, 5, 15 and 30 min, 1, 2, 3, 4, 6, 9, 12, 18 and 24 hrs (and 36, 48 and 72 hrs following dosing Day 1 for cohort 2 and 3)	No