AZD9668 Relative Bioavailability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035411
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: AZD9668 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035411

Research Site
Berlin, Germany
Sponsors and Collaborators
Study Director: Emma Harrop AstraZeneca R&D
Principal Investigator: Rainard Fuhr Parexel

Responsible Party: AstraZeneca Identifier: NCT01035411     History of Changes
Other Study ID Numbers: D0520C00007
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: February 2010

Keywords provided by AstraZeneca:

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