AZD8683 Multiple Dose Study in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01584739 | Terminated Phase 1

• 2 other identifiers: D1883C00002Eudract 2011-005588-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of AZD8683 in Healthy volunteers and repeated inhalation of one dose level of AZD8683 in patients with chronic obstructive pulmonary disease given once daily.

Conditions

COPD

Keywords

Safety; tolerability; healthy; COPD (chronic obstructive pulmonary disease); pharmacokinetic; pharmacodynamic; inhaled

Outcome Measures

Primary Outcomes (1)

• Safety profile in terms of: adverse events, Supine vital signs (blood pressure and pulse rate), body temperature, ECG, Physical examinations, Laboratory variables (clinical chemistry, haematology and urinalysis), Spirometry

  No formal statistical tests will be performed

  Up to 13 days post dose.

Secondary Outcomes (8)

• AZD8683 single dose pharmacokinetics from blood and urine in healthy volunteers.

  Blood: From days 1 and 15 - Pre-dose, 5, 15 and 30mons, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 hrs (also 96 and 120hrs and follow-up). Urine: From days 1 and 15: pre-dose and 6, 12, 24, 48 and 72hrs.

• AZD8683 multiple dose pharmacokinetics from blood and urine in healthy volunteers.

  Blood: From days 1 and 15 - Pre-dose, 5, 15 and 30mins, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, 48, 72 hrs (also 96 and 120hrs and follow-up). Urine: From days 1 and 15: pre-dose and 6, 12, 24, 48 and 72hrs.

• Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : FEV1 and FVC.

  Predose, 5mins, 30mins, 1hr, 2hrs, and 4hrs on days 1 and 15.

• Description of the pharmacodynamic (PD) effects of AZD8683 in COPD patients in terms of : FEV1 and FVC.

  Predose, 5mins, 30mins, 1hr, 2hrs and 4hrs on days 1 and 12.

• Description of the pharmacodynamic (PD) effects of AZD8683 in healthy volunteers in terms of : supine blood pressures and pulse rate.

  Pre-dose, 30mins, 60mins, 90 mins, 2hrs and 4hrs, on days 1 and 15.

Study Arms (2)

AZD8683

EXPERIMENTAL

Drug: AZD8683

Placebo to AZD8683

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD8683 DRUG

Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients)

AZD8683

Placebo DRUG

Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients

Placebo to AZD8683

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male volunteers and healthy female volunteers of non-child bearing potential, aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture - Healthy volunteers
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg inclusive - Healthy volunteers and COPD patients
• Be able to inhale from the Turbuhaler® inhaler according to given instructions as well as be able to perform spirometry -Healthy volunteers and COPD patients.
• Male COPD patients or female COPD patients of non-childbearing potential (post menopausal or surgically sterilised) aged ≥40 years at Visit 1 - COPD patients
• Female healthy volunteers and female patients ≤60 years must have a negative pregnancy test at screening and on admission to the unit - Healthy volunteers and COPD patients

You may not qualify if:

• Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome - Healthy volunteers and COPD patients
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8683 or excipients:Healthy volunteers and COPD patients
• History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs - Healthy volunteers and COPD patients
• Any clinically significant illness (other than COPD), medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - COPD patients
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product - Healthy volunteers

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Carin Jorup

  AstraZeneca Research and Development SE-431 83 Molndal Sweden

  STUDY DIRECTOR

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: April 2, 2012
• First Posted: April 25, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

GB (1)