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AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations

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.
 
ClinicalTrials.gov Identifier: NCT00918398
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : July 30, 2009
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 10, 2009
First Posted Date  ICMJE June 11, 2009
Last Update Posted Date July 30, 2009
Study Start Date  ICMJE June 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
PK samples for AZD1981 from both blood and urine [ Time Frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose. ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
PK samples for AZD1981 from borh blood and urine [ Time Frame: Intense PK-sampling during the 24 hours following dose and additional samples up to 60 hours after dose. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2009)
Safety variables (adverse events and laboratory safety lab) [ Time Frame: Adverese events registered during study and vital signs and ECG at visit 1,2 ,6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AZD1981 Bioavailability Study of Intravenous (IV) and Oral Formulations
Official Title  ICMJE An Open, Single-dose, Phase I, 4-period Partly Crossover Study in Healthy Men or Women to Assess Relative Bioavailability of Oral Administration of AZD1981 Via Tablets Compared With Suspension and Basic Systemic Pharmacokinetic Parameters After Intravenous Administration
Brief Summary The primary objective is to investigate the pharmacokinetics of AZD1981 given in different formulations and to measure renal clearance
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Postmenopausal
  • Surgically Sterile Women
Intervention  ICMJE
  • Drug: AZD1981
    100 mg iv infusion, single dose, 4 hours infusion
  • Drug: AZD1981
    514 mg oral solution, single dose
  • Drug: AZD1981
    500 mg oral tablet A (optimal dissolution) give as 2x250 mg tablets, single dose
  • Drug: AZD1981
    500 mg oral tablet B (slower dissolution) give as 2x250 mg tablets, single dose
Study Arms  ICMJE
  • Experimental: 1
    AZD1981, 100 mg iv infusion
    Intervention: Drug: AZD1981
  • Experimental: 2
    AZD1981, 514 mg oral solution
    Intervention: Drug: AZD1981
  • Experimental: 3
    AZD1981, 500 mg oral tablet A
    Intervention: Drug: AZD1981
  • Experimental: 4
    AZD1981, 500 mg oral tablet B
    Intervention: Drug: AZD1981
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 10, 2009)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures
  • Men or post-menopausal or surgically sterile women, aged 18 to 55 years
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to Visit 1 (pre-entry)

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the subject at risk because of his participation in the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00918398
Other Study ID Numbers  ICMJE D9831C00003
EudraCT No. 2009-010964-40
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christer Hultquist, Medical Science Director, AstraZeneca R&D Lund, Sweden
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eva Pettersson AstraZeneca R&D, Lund, Sweden
Principal Investigator: Elisabeth Eden Quintiles AB, Uppsala, Sweden
PRS Account AstraZeneca
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP