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

NCT01817855 | Completed Phase 1 Results

• 1 other identifier: D2550C00002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Healthy Subjects

Keywords

Phase 1,; Safety,; Tolerability,; Healthy,; COPD patients

Outcome Measures

Primary Outcomes (1)

• Adverse Events

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

  Up to 24 days

Secondary Outcomes (3)

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

  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)

  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 (Cmin)

  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.

Study Arms (2)

1

EXPERIMENTAL

Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo.

Drug: AZD7624

2

PLACEBO COMPARATOR

Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo.

Drug: Placebo to match

Interventions

AZD7624 DRUG

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

1

Placebo to match DRUG

Multiple doses inhaled placebo via a nebulizer

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

AZD7624

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Naimish Patel
• Organization: AstraZeneca

Naimish.Patel@astrazeneca.com

+1 781 839 4061

Study Officials

• Saeed Khan, MBBS, MRCP

  Quintiles Drg Research Centre At Guys Hosipital, 6 Newcomen Street London SE1 1YR

  PRINCIPAL INVESTIGATOR

• Naimish Patel, MD

  AstraZeneca, Wilmington, US

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 26, 2013
• Study Start: September 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 30, 2016
• Results First Posted: March 30, 2016

Record last verified: 2016-02

Locations

GB (1)