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AZD9668 Relative Bioavailability

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01034982
First received: December 14, 2009
Last updated: February 4, 2010
Last verified: February 2010
History of Changes
  Purpose

The study is designed to investigate the pharmacokinetic behaviour of the free base formulation of AZD9668. The study will compared the relative bioavailability of the free base formulation at two different dose levels compared to the tosylate salt formulation.


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: A Phase I Open-label, Single-centre, Two Cohort Crossover Study to Assess the Relative Bioavailability After Oral Administration of AZD9668 Free Base Dosed as a Suspension Compared to AZD9669 Tosylate Salt Dosed as a Tablet

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 the free base of AZD9668 dosed as a suspension compared to the tosylate salt of AZD9668 dosed as a tablet formulation at two dose levels. [ Time Frame: Frequent sampling occasions during the study ] [ Designated as safety issue: No ]

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

Enrollment: 28
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
tosylate salt tablet
 Drug: AZD9668
20 mg
Experimental: 2
free suspension
 Drug: AZD9668
20 mg
Experimental: 3
tosylate salt tablet
 Drug: AZD9668
60 mg
Experimental: 4
free suspension
 Drug: AZD9668
60 mg

  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).
  • 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
  • History of cardiac arrhythmia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034982

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: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01034982     History of Changes
Other Study ID Numbers: D0520C00017
Study First Received: December 14, 2009
Last Updated: February 4, 2010
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 19, 2013