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AZD9668 Relative Bioavailability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01035411
First received: December 14, 2009
Last updated: January 28, 2013
Last verified: February 2010
History of Changes
  Purpose

This clinical study will aid future formulation development and optimisation of AZD9668 tablets by evaluating possible effects of minor changes to the formulation and process on the rate and extent of absorption.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: AZD9668
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-label, Single-centre, 3-way Single Dose Crossover Study to Assess the Relative Bioavailability After Oral Administration of a Tablet Variant of AZD9668 Compared to AZD9668 Tablets and to Further Investigate the Safety and Tolerability of AZD9668 in Healthy Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of a tablet variant of AZD9668 compared to AZD9668 tablets. [ Time Frame: Frequent sampling occasions during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables (adverse events, vital signs, haematology, clinical chemistry, urinalysis and 12-lead ECG) [ Time Frame: Frequent sampling occasions during the study ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD9668 2X30mg tablet
 Drug: AZD9668
2 x 30 mg batch DLE494
Drug: AZD9668
2 x 30 mg batch DLF497
Drug: AZD9668
2 x 30 mg tablet variant 1

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of informed consent prior to any study-specific procedures
  • female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile) or of child bearing potential
  • Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg.
  • Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV-1/2 at the screening visit
  • Be a none smoker or ex-smoker who has stopped smoking for >6 months prior to visit 2 (pre-entry)

Exclusion Criteria:

  • Any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs.
  • Any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study
  • Any ECG abnormality (including cardiac arrhythmia) which in the opinion of the investigator may put the subject at risk
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035411

Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Emma Harrop AstraZeneca R&D
Principal Investigator: Rainard Fuhr Parexel International GmbH
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01035411     History of Changes
Other Study ID Numbers: D0520C00007
Study First Received: December 14, 2009
Last Updated: January 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013