Clinical trial NCT01817855: To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Healthy Subjects
Keywords: Phase 1,
Safety,
Tolerability,
Healthy,
COPD patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 24 days
Secondary outcomes:
measure: Summary of Pharmacokinetic Parameters (AUC(0-tau) )
timeFrame: 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.
measure: Summary of Pharmacokinetic Parameters (Cmax)
timeFrame: 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.
measure: Summary of Pharmacokinetic Parameters (Cmin)
timeFrame: 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.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Quintiles Drg Research Centre At Guys Hosipital, 6 Newcomen Street London SE1 1YR
name: Saeed Khan, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, Wilmington, US
name: Naimish Patel, MD
role: STUDY_CHAIR
References: