A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT00703391 | Completed Phase 2 Results

• 1 other identifier: D0520C00002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic; obstructive; pulmonary; lung; respiratory disease; tolerability; placebo-controlled; pharmacokinetics; COPD

Outcome Measures

Primary Outcomes (16)

• Alanine Aminotransferase (ALT)

  ALT level greater than 3 times the upper limit of normal

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Aspartate Aminotransferase (AST)

  AST level greater than 3 times the upper limit of normal

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Creatine Kinase (CK)

  Change from baseline to Day 14

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Total Bilirubin

  Change from baseline to Day 14

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Creatinine

  Creatinine level greater than the upper limit of normal

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Haemoglobin (Hb)

  Change from baseline to Day 14

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Reticulocytes

  Change from baseline to Day 14

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Leucocytes

  Change from baseline to Day 14

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)

  QTcF interval greater than 450 ms

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• QTcF

  QTcF change from baseline greater than 60 ms

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• FEV1 (Forced Expiratory Volume in the First Second)

  Change from baseline to Day 14

  Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)

• Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))

  AUC(0-12) following 14 days' dosing

  Pre-dose on day -1 to day 15 (end of dosing)

• Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)

  Cmax following 14 days' dosing

  Pre-dose on day -1 to day 15 (end of dosing)

• Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)

  tmax following 14 days' dosing

  Pre-dose on day -1 to day 15 (end of dosing)

• Terminal Half-life of Drug in Plasma (t1/2)

  t1/2 following 14 days' dosing

  Pre-dose on day -1 to day 15 (end of dosing)

• Renal Clearance of Drug From Plasma (CLR)

  CLR following 14 days' dosing

  Pre-dose on day -1 to day 15 (end of dosing)

Secondary Outcomes (4)

• Sputum Absolute Neutrophil Count

  Pre-dose day -1 to post-dose on day 14

• Sputum Differential Neutrophil Count

  Pre-dose day -1 to post-dose on day 14

• AZD9668 Sputum Concentrations

  Pre-dose day -1 to post-dose on day 14

• Quantitative Sputum Bacteriology

  Pre-dose day -1 to post-dose on day 15

Study Arms (2)

1

EXPERIMENTAL

Active Treatment

Drug: AZD9668

2

PLACEBO COMPARATOR

Placebo Treatment

Drug: Placebo

Interventions

AZD9668 DRUG

30mg oral tablets twice daily (bid) for 14 days

1

Placebo DRUG

Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild to moderate COPD
• Smokers or ex-smokers
• post-menopausal females

You may not qualify if:

• Past history or current evidence of clinically significant heart disease
• Lung disease other than COPD
• Treatment with systemic steroids within 8 weeks of study visit 2
• Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Berlin, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiolitis Obliterans Syndrome; Respiration Disorders

Interventions

N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Kristina Panke

  Parexel International GmbhH (CRO)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 26, 2012
• Results First Posted: December 29, 2010

Record last verified: 2012-01

Locations

DE (1)